Showing posts with label MEBO. Show all posts
Showing posts with label MEBO. Show all posts

Thursday, March 23, 2023

Lactobacillus, Bifidobacterium and other emerging probiotics

In the past few decades, Lactobacillus and Bifidobacterium genera were the main bacteria to be used as probiotics. One of the reasons for such attention was that these bacteria have the ability to thrive aerobically and are simple to package for sale. Cass Nelson-Dooley and Tony Hoffman of Metametrix (acquired by Genova Diagnostics in 2012) talked about these probiotics in MEBO interviews in 2009, emphasizing that high levels of Lactobacillus could be bad in some cases. Diets rich in simple carbs, poor absorption and small intestinal pockets can feed and trap excess Lactobacillus. Adding probiotics Bifidobacteria or Saccharomyces boulardii and prebiotic fiber to the diet could, in their opinion, help the MEBO population. D-lactate was one of the tests they offered that measured the level of this byproduct of bacterial fermentation, indicating an overgrowth of bacteria in the small intestine. According to our early clinical studies, D-lactate, however, was elevated in less than 20% of MEBO and PATM populations. 

Even though Lactobacillus is only a minor member of the human colonic microbiota, the proportions of those bacteria and particular strains are frequently either positively or negatively correlated with human disease and chronic conditions. Although it generally is not considered a pathogen, it can cause disease in compromised hosts, including bacterial endocarditis, pleuropulmonary infections, gastrointestinal abscesses, urinary tract infection, conjunctivitis, dental caries, and endometritis. Lactobacillus bacteremia, presumably secondary to bacterial translocation from the gastrointestinal tract, has been reported in a patient with severe intestinal inflammation caused by ulcerative colitis. A decrease in genus Faecalibacterium and increase in Lactobacillaceae has been previously reported in patients with constipation (Lactiplantibacillus plantarum P9 supplementation, on the other hand, helped to increase frequency of bowel movements). Compared to healthy individuals, pediatric and adult Crohn's disease (CD) patients had an increased relative abundance of Lactobacillus species. In both cases, Lactobacillus enrichment coincided with depletion of F. prausnitzii - that could represent a good candidate as next-generation probiotic.

The percentages of Bifidobacterium and the Lactobacillus group presented a decreasing trend in patients with quiescent ulcerative colitis (UC) compared to active UC, although no significant differences were observed. Excessive amounts of Bifidobacteria can have negative effects on the body, such as in the case of Bifidobacterium breve bacteremia caused by excessive probiotic supplementation in infants with gastrointestinal conditions. On the other hand, Lactobacillus, Bifidobacterium and F. prausnitzii are depleted in IBS patients, resulting in lower SCFA concentrations (short-chain fatty acids, which are organic acids produced by gut bacteria during fermentation of indigestible foods) compared with healthy individuals. Maternal prenatal stress could also cause lower levels of Lactobacillus and Bifidobacterium and keep them low even later in life. With lower levels of Bifidobacterium, celiac patients have an imbalance in the intestinal microbiota, regardless of pH, even while on a gluten-free diet. Hormone treatment affects Bifidobacterium longum's ability to produce acids: progesterone reduces lactic acid and acetic acid production, while estradiol and thyroxine increase levels of both lactic acid and acetic acid (ethinyl estradiol) or lactic acid and butyric acid (thyroxine hormone). 

Data from our microbiome study (NCT03582826: Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions  - ClinicalTrials.gov) show that while there was a general trend of increasing levels of Bifidobacteria and Lactobacillus in individuals who achieve remission, less than 10% of participants needed to boost levels of both species to improve their condition. In line with previous knowledge, in MEBO/PATM population, Bifidobacteria (one of the first microbes to colonize the human gastrointestinal tract) was more common in younger individuals. About one third of the participants experienced lesser symptoms when increasing levels of their gut Bifidobacteria, another third benefited from more Lactobacillus and the remaining third felt better when increasing levels of Faecalibacterium prausnitzii (a butyrate-producing anaerobe typically associated with good health). Changes in the levels of these bacteria corresponding to recovering are overlayed on Figure 5 from our paper published in JMIR dermatology. It was illustrating changes in microbial diversity vs abundances of selected bacterial species associated with odor (CSS) for 12 female (F1-F12) and 10 male (M1-M19) participants who self-reported both flare-ups (beginning of the arrow) and improvements (end of the arrow). We added text boxes showing whether the levels of F. prausnitzii (F), Bifidobacterium (B) and Lactobacillus (L) are increasing (馃」) , decreasing (馃』) or fluctuating (馃『) as symptoms resolve. It is obvious that individuals with the highest bacterial diversity don't benefit from increasing levels of probiotic diversity, while those with low diversity levels do need more probiotic microbes in their system. The figure demonstrates the complexity of these bacterial perturbations and emphasizes the need to consider more than just three species when predicting which treatment will work best for reducing MEBO and PATM symptoms. 

As we mentioned in the previous blog post, Lactobacillus is the main genera responsible for odors of the uncooked food waste. Some strains of Lactobacillus produce lactic acid, which can contribute to a more acidic environment in the gut. This can be beneficial for some people, but for others it can exacerbate odor issues. Bifidobacteria could also produce organic acids such as acetic acid and lactic acid in addition to short-chain fatty acids (SCFAs) like butyrate, which can have anti-inflammatory effects and promote gut health, but some people may find it unpleasantly smelling. F. prausnitzii produces a range of metabolites including one of the worst smelling compounds Putrescine. F. prausnitzii  plays important role in balancing immunity. Its butyrate production has been correlated to the capacity to induce IL-10, an anti-inflammatory cytokine, in peripheral blood mononuclear cells (PBMC) but not to the ability to block IL-8 secretion in TNF-伪-stimulated HT-29 cells. In COVID-19, Faecalibacterium prausnitzii has been inversely correlated with disease severity. 

Research has shown that the gut microbiome is far more complex than previously thought, with hundreds of bacterial species interacting in a delicate balance.  Therefore, focusing solely on Lactobacillus and Bifidobacterium, or any other bacterium, may not be enough to promote a healthy gut microbiome for everyone. Besides, different strains of bacteria within the same species can have different effects on the body.

After more than a century of research, the following species are identified as the primary probiotic species of Lactobacillus species: L.acidophilus, L.casei, L.fermentum, L.gasseri, L.johnsonii, L.paracasei, L. plantarum, L. rhamnosus, and L. salivarius. For Bifidobacteria these are: B.adolescentis, B.animalis, B.bifidum, B.breve, and B.longum. We are learning more about strains of these species. Novel probiotic strain Bifidobacterium bifidum CECT 7366 is active against the pathogenic bacterium Helicobacter pylori - and so are variations of Saccharomyces Boulardii and Lactobacilli johnsonii. Another strain L. plantarum 299v can directly interfere with E. coli colonization and improve the immunological status of the intestinal mucosa although these results have not yet been confirmed in humans. Lactobacillus GR-1 and B-54 or RC-14 strains in the vagina has been shown to reduce the risk of urinary tract infections. Mileti et al. found that Lactobacillus paracasei displayed a delay in the development of colitis and a decreased severity of disease but that L. plantarum and L. rhamnosus GG exacerbated the development of dextran sodium sulfate (DSS)-induced colitis. Bifidobacterium supplemented with various fiber additives can prevent the growth of Clostridium difficile, while Lactobacillus salivarius protects the broiler chicks from Salmonella infections. Several strains of other species promising as probiotics are from Roseburia spp., Akkermansia spp., and Faecalibacterium spp. Probiotic potential risk score (PPRS) allowed to classify 84 Faecalibacterium prausnitzii strains  into low-, medium-, and high-risk groups. 15 strains identified as low-risk strains are prioritized for clinical application. 

Unfortunately, the extreme oxygen sensitivity of F. prausnitzii imposes practical challenges to the production, transportation, storage, and manufacturing of probiotic products to be evaluated in a clinical setting. Instead, we have to turn to prebiotics - a type of dietary fiber - in our food . F. prausnitzii's growth is promoted by inulin, inositol (vitamin B8) and fructo-oligosaccharides, chicory roots, wheat, onion, banana, garlic, and leek, wheat, rye, rice, barley, oat, and sorghum, and gold kiwifruit

Gut microbiota can be also influenced by phytochemicals. In one study, black raspberry (BR) reduced the serum levels of trimethylamine-N-oxide and cholesterol in rats fed excessive choline with a high-fat diet (HFC). The authors hypothesized that since gut microbiota plays a crucial role in the production of trimethylamine and microbial metabolites, BR could influence gut microbial composition. Their study examined microbiomes and metabolomes of rats and showed that the BR supplementation enriched Bifidobacterium and reduced Clostridium cluster XIVa. 

While we have made significant progress in understanding the role of probiotics and prebiotics in supporting our gut health, it's important to recognize that there is still a great deal that we don't know. It's becoming increasingly clear that a personalized approach to prebiotic and probiotic use may be necessary to achieve optimal health outcomes. This approach involves paying attention to how different foods make you feel and adjusting your diet accordingly, while eating a diverse and balanced diet that incorporates a variety of whole foods and phytochemicals, staying hydrated, getting enough sleep and exercise, and managing stress levels. Focusing on overall health and well-being will help to support the body's natural ability to maintain a healthy microbiome and avoid dysbiosis-related health issues.



REFERENCES


Din AU, Hassan A, Zhu Y, Yin T, Gregersen H, Wang G. Amelioration of TMAO through probiotics and its potential role in atherosclerosis. Applied Microbiology and Biotechnology. 2019 Dec;103:9217-28.

Pacifico L, Osborn JF, Bonci E, Romaggioli S, Baldini R, Chiesa C. Probiotics for the treatment of Helicobacter pylori infection in children. World J Gastroenterol 2014; 20(3): 673-683 [PMID: 24574741 DOI: 10.3748/wjg.v20.i3.673] 

Lim T, Lee K, Kim RH, Ryu J, Cha KH, Park SY, Koo SY, Hwang KT. Effects of black raspberry extract on gut microbiota, microbial metabolites, and expressions of the genes involved in cholesterol and bile acid metabolisms in rats fed excessive choline with a high-fat diet. Food Sci Biotechnol. 2023 Feb 13;32(4):577-587. doi: 10.1007/s10068-023-01267-4. PMID: 36911337; PMCID: PMC9992478.

Heeney DD, Gareau MG, Marco ML. Intestinal Lactobacillus in health and disease, a driver or just along for the ride?. Current opinion in biotechnology. 2018 Feb 1;49:140-7.

Mart铆n R, Miquel S, Benevides L, Bridonneau C, Robert V, Hudault S, Chain F, Berteau O, Azevedo V, Chatel JM, Sokol H. Functional characterization of novel Faecalibacterium prausnitzii strains isolated from healthy volunteers: a step forward in the use of F. prausnitzii as a next-generation probiotic. Frontiers in microbiology. 2017 Jun 30;8:1226.

Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N. Post-acute COVID-19 syndrome. Nature medicine. 2021 Apr;27(4):601-15.

Bai Z, Zhang N, Jin Y, Chen L, Mao Y, Sun L, Fang F, Liu Y, Han M, Li G. Comprehensive analysis of 84 Faecalibacterium prausnitzii strains uncovers their genetic diversity, functional characteristics, and potential risks. Frontiers in Cellular and Infection Microbiology. 2023 Jan 4;12:1924.

Gabashvili I.S. Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial. JMIR Dermatol 2020;3(1):e10508 URL: https://derma.jmir.org/2020/1/e10508 DOI: 10.2196/10508

Friday, July 2, 2021

Viruses and Vaccines

The COVID-19 Back-to-normal study was initiated in January 2021 as an effort of a tight-​knit neighborhood to help each other avoid the virus and vaccinate safely.

Later the research protocol was approved by MEBO Research IRB and the study was open to other communities around the world. 

By now, we have over 600 participants. 

Early results of the study in MEBO/PATM community, based on the replies of the first 26 enrollees, showed that while reactions to vaccine were similar to the general population, experiences with COVID-19 infections were not - 2 individuals were not able to avoid the disease in this group, and both of them experienced long term effects. 

As of today, we have stories from 41 members of MEBO/PATM community and 6 different vaccines: AstraZeneca-Oxford, Johnson & Johnson’s single-shot, Moderna, Pfizer-BioNTech, Sinovac Biotech’s CoronaVac and BBIBP-CorV, also known as the Sinopharm vaccine.

Currently, in various areas of the world, 19 COVID-19 vaccines have been authorized for use. Statistics on short-term effects of these vaccines have been published for different groups. If we compare our data to published data matching by ages and vaccines, short-term effects are very similar. Some of our sub-groups, especially healthy elderly participants, experienced far fewer side effects than reported in the literature. There were slightly fewer common adverse reactions in MEBO Pfizer group, but incidences of fatigue were on a higher side for all vaccines, and there were more reports of fever experienced after Moderna and Astrazeneca, albeit it was not significantly different from the general population. More significant differences were for less common and longer-term effects including fast heartbeat, dry mouth, skin reactions and swollen lymph nodes. The figure below shows common symptoms for Long COVID. Underlined are some of the issues reported after COVID vaccine uptakes in the group. Possible worsening of MEBO/PATM symptoms after vaccinations was reported by 10% of study participants. 

The most significant difference of MEBO group from the general population is the response to COVID-19 infection. 6 people (3 males, 3 females) out of 41 study participants experienced COVID-19 and all of them had long-term reactions. 5 out of 6 considered themselves long-haulers. The 6th person reported persistent MEBO/PATM issues  post-acute COVID-19. That's 80-100% of long-haulers, ~4 times more than researchers estimate! Our rate is closer to some groups with severe genetic conditions - such as individuals with hypohidrotic ectodermal dysplasia  - predisposing to bad smell from nostrils. 

Postinfectious fatigue was the most commonly reported symptom in this group. Long-lasting loss of smell happened in ~16% - as in the general population. MEBO/PATM symptoms were significantly increased, unless well under control before the infection. There's anecdotal evidence, based on posts in social media, that some sufferers of chronic COVID-19 are experiencing more aversive underarm smell. 7% of long-haulers are thought to sense phantom distorted smells. Is it really imagined smells or could it be real change in their odor?

We also had reports of successful management of persistent COVID symptoms with a low histamine, gluten-free, dairy-free and no carb diets.

Why is MEBO/PATM community more susceptible to long COVID? A new study argues that long-haulers might actually be experiencing an attack of fatigue-inducing Epstein-Barr virus (EBV, a member of herpesvirus family HHV-4) that was lying dormant in their bodies.  For this study, Gold and his colleagues analyzed blood of 30 people with chronic COVID (out of 185 COVID survivors). 20 out of these 30 carried high levels of EBV antibodies. Vaccines were shown to reactivate viruses too, in much rarer cases. As was demonstrated for Pfizer vaccine that woke up another herpes virus, chickenpox herpes-zoster (HHV-3), that causes shingles when reactivated (this happened to 1% of patients with autoimmune inflammatory rheumatic diseases). Herpes simplex (HSV-1) can be also kept in remission by a healthy immune system and can be also reactivated by COVID-19.

MEBO and PATM symptoms could arise following an infection. Perhaps SARS-CoV-2 can reactivate the old viruses that caused these symptoms to begin with? 

Community immunity (also known as herd immunity) protects everyone. We hope that MEBO/PATM community stays COVID-free and safe. 



REFERENCES

Gabashvili IS. Community-Based Phenotypic Study of Safety, Tolerability, Reactogenicity and Immunogenicity of Emergency-Use-Authorized Vaccines Against COVID-19 and Viral Shedding Potential of Post-Vaccination Infections: Protocol for a prospective study medRxiv 2021.06.28.21256779; doi: https://doi.org/10.1101/2021.06.28.21256779

McDonald I, Murray SM, Reynolds CJ, Altmann DM, Boyton RJ. Comparative systematic review and meta-analysis of reactogenicity, immunogenicity and efficacy of vaccines against SARS-CoV-2. npj Vaccines. 2021 May 13;6(1):1-4.

Gold JE, Okyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and Its Relationship to Epstein-Barr Virus Reactivation. Pathogens. 2021 Jun;10(6):763.

Monday, June 21, 2021

COVID-19 and vaccine reactogenicity in MEBO/PATM community

Infections have been shown to alter body odor and so have immunizations. So far, only nonhuman animals were able to detect the subtle changes in chemical makeup after vaccinations and even their sensitive noses were not able to differentiate between different vaccines - such as the rabies virus or the West Nile virus vaccines [Kimball et al, 2014]. However, this was the case of very mild reactions to immunization. Even slightly stronger inflammatory responses, to relatively weak immune challenges, can, indeed, be detected by human noses [Gordon et al, 2018]. Urine and axillary odor are becoming slightly more aversive in healthy humans, as a function of immune activation. But this is not supposed to last too long.

Our preliminary results, based on responses to the survey for 24 members of MEBO community and 6 of their family members show a wide variety of reactions to Astrazeneca, J&J, Moderna, Pfizer and Sinovac/Coronavac vaccines. 

Interestingly, Pfizer vaccine that caused no or very mild reactions in several MEBO participants, was also the vaccine that possibly caused temporary worsening of odor symptoms in one person in the community. Another MEBO participant that reported possible worsening of odor from Moderna vaccine had one thing in common with the other individual - they both had pre-existing conditions related to their upper digestive tract. Some Astrazeneca recipients also reported odor issues but did not think it was worse than usual. 

One of the most interesting observations was that even though only 2 members of MEBO/PATM community reported COVID-19 infection (before or between vaccinations), both of them had long COVID with long-term neurological manifestations such as fatigue, ENT symptoms and loss of smell.

Adverse reactions to COVID-19 vaccines are influenced by a multitude of factors, many of which can be anticipated and alleviated. A certain level of inflammation is needed to trigger an effective adaptive immune response, but both environment and genetic makeup determine who is more likely to experience particular symptoms after infection and from the vaccine.

You can help by telling us about your experiences with COVID-19 and/or vaccinations. These surveys can be used for posting your brief stories - no need to answer all the questions. And you can always add to your story later. Please use your anonymous ID and let us know if you have any questions.

Survey

in English:  https://bit.ly/BTN-eng

en Espa帽ol: https:/bit.ly/BTN-esp


We'll be posting more observations and comparisons with over 600 participants of our study from other communities. 


REFERENCES

Blumental S, Debr茅 P. Challenges and issues of anti-SARS-CoV-2 vaccines. Frontiers in Medicine. 2021;8.

Gordon AR, Kimball BA, Sorjonen K, Karshikoff B, Axelsson J, Lekander M, Lundstr枚m JN, Olsson MJ. Detection of inflammation via volatile cues in human urine. Chemical senses. 2018 Nov 1;43(9):711-9.

Kimball BA, Opiekun M, Yamazaki K, Beauchamp GK. Immunization alters body odor. Physiology & behavior. 2014 Apr 10;128:80-5.


Wednesday, November 4, 2020

New Paper Reveals Insights into Bacteria that Live on Your Skin and in Your Gut

What do MEBO (metabolic body odor), PATM ("People are Allergic to ME" condition) and TMAU (trimethylaminuria) have in common - beside the obvious:  airborne substances that make people feel uncomfortable?  New paper published in JMIR Dermatology - Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and PATM Conditions - demonstrates: it's microorganisms that live on the skin and can be also present in the gut. The results of a clinical trial reported in this paper showed that the same microbes can modulate severity of odor or allergic reactions in others independently of genetics and trimethylamine metabolism. 

MEBO paper in JMIR Dermatology

Researchers long suspected that there was a link between gut and skin health. Recent studies have confirmed it for a number of inflammatory skin diseases - such as psoriasis, rosacea, acne and atopic dermatitis. Microbes have been also suggested as targets for treating TMAU, a disorder that causes the body to constantly emit foul odor - from the skin, the mouth and the nose - via skin or fecal microbiome transplantation, antibiotics and probiotics. However, existing treatments are too broad, can lead to other health problems and lack understanding of precise targets and mechanisms. 

The paper shows that MEBO and PATM conditions don't always arise because of the decrease in microbial diversity. About half of the people might be lacking in microbial richness, but another half has too many different bacterial species to handle. 

The figure shows results of 22 study volunteers that were able to observe both flare-ups and improvements in their condition. The Y axis shows changes in microbial diversity vs abundances of selected bacterial species (X axis) for 12 female and 10 male participants. The arrows are labeled with 3 or 4 digits - the last digits of MEBO ID. Beginning of the arrow shows participants' microbial diversity and proportion of skin microbes in the gut during flare-ups, the end of the arrow points to improvements. As this figure shows, the only exceptions to the conclusion that the fewer cutaneous bacteria in the gut, the fewer skin emanations were 1214, 1287 and 1307. All of them observed very minor if not negligible (and easy to misinterpret) improvement of their condition (flare-ups happening from “all the time” to “most of the time”). 1214 was seen by a professional dermatologist, who concluded that a diagnosis of bromhidrosis didn’t seem warranted. 1307 had undergone a Botox procedure to treat hyperhidrosis, but was still experiencing symptoms (and, from our results, large fluctuations in odorous skin bacteria). 1287 did not report any skin odors and noted only halitosis. 

Read the paper to learn more and stay tuned for more details as they develop.


REFERENCE


Gabashvili IS  Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial
JMIR Dermatol 2020;3(1):e10508
DOI: 10.2196/10508


Monday, February 10, 2020

Microbial diagnostics of MEBO

There are many medical conditions for which there are no standard tests for definite diagnosis and no established cures.  Diagnosing and curing Metabolic Body Odor (MEBO) is even more difficult. Especially because MEBO is an umbrella term for several different conditions.

Tuesday, December 17, 2019

Age and Metabolic Body Odor

Saturday, November 30, 2019

Concluding the MEBO-uBiome study

We are very close to concluding our clinical trial NCT03582826 ​according to the pre-specified protocol. 

Recruitment for our microbiome study commenced in June 2018 and completed in December 2018. The last batch of raw FASTQ sequences and raw taxonomy-level abundance summaries was received in October 2019. We had to spend more time on collecting and processing annotation data (medical histories, dietary intakes, medications, etc), ensuring quality, completeness, consistency and validity, and defining best approaches of dealing with "missing values".

We have now completed final data collection for the primary and secondary outcome measures.

...  Read more ... 

Wednesday, September 4, 2019

The Anna Karenina Principle: Alloprevotella

"All happy families are alike; each unhappy family is unhappy in its own way", said the great novelist. The Anna Karenina principle (AKP), in the context of metabolic disorders, would mean that an uncompensated deficiency in any one of important enzymes, or presence of any one of pathogenic microorganisms, dooms the person to having the MEBO/PATM symptoms.

... Read more ...

Sunday, July 21, 2019

How do you feed your microbiome?

As we are gearing up for final stage of our clinical study NCT03582826, we are looking at different subgroups of our participants, to find more precise, personalized and powerful solutions for everyone. 

We know, that genes and environment always combine to make us who we are. We already talked about some of those seemingly less important genes - such as ABO blood group. The environmental factors include diet, exercise, social environments (such as social support), varying conditions and situations.   

According to descriptions of diets and lifestyle submitted by our participants, about 25% of them are taking commercial probiotic products, about the same number as those who had chicken as the main staple of their kitchen (see word cloud depiction of diet keywords on the right). About 2% take commercial prebiotics, but many more eat prebiotic foods (such as oats/oatmeal, bananas, apples and nuts shown in green). 4% eats onions and about the same percentage actively avoids it.  Milk, Rice, Bread and Pasta were among the most popular foods, after chicken. 

The world is eating less meat overall, and a few years ago, among the meat eaters, the scale tipped from greater consumption of beef to greater consumption of chicken.
This is even more pronounced in MEBO population. 

Half of MEBO population takes vitamins and  supplements.  The most popular among them is Zinc closely followed by Magnesium and Enzymes. Also popular are multivitamins, Calcium,  Resveratol, Vitamin B12, Charcoal, Chlorophyll, Ashwagandha, Biotin, Primrose oil, Omega 3 and Livercare. Blood pressure drugs are among the most used medications.

This information will be useful in understanding differences in microbiomes of subjects with similar symptoms. We might already be observing interesting trends. Certain supplements, for example, seem to benefit some blood group more than others. Same about foods naturally rich in certain minerals and vitamins.

We'll talk about this next time.

Friday, November 30, 2018

On what's in your head, the downside of diversity and deodorizing bacteria: preliminary results of NCT03582826

Mirrored from Aurametrix, preliminary results of NCT03582826:

By now, 105 uBiome kits were registered in our Quality of Life form (out of 300+ sets sent). 16 volunteers have submitted all 3 samples and 23 registered one or two kits. Over half of our participants have not yet started the study. We hope that this post will answer some of their questions on where to start.

The goal of MEBO Gut Microbiome study is to identify microbial communities associated with flare ups and remission of systematic malodor or PATM conditions.  Participants are asked to answer MEBO Quality of Life (QoL) questionnaire about the last 24 hrs before every sample is taken. The Questionnaire is embedded into English and Spanish posts about the study.  The answers are used to calculate total QoL score that increases with less odor and more wellbeing. The questionnaire evaluates physical health, psychological health, social support and environment such as diet and exercise. A separate score is calculated for MEBO (malodor/PATM) symptoms.

This post is about preliminary results of the first 41 uBiome kits representing samples from 24 participants. Quality of Life scores varied from 55 to 149 (best, "ideal" quality of life would be 150), while MEBO scores ranged from 3 (experienced MEBO/PATM symptoms "all the time" and odor was lingering for hours at 10 feet and farther) to 25 (100% odor free).

The pie chart on the right shows social environment for MEBO volunteers: almost half of study participants had active social lives interacting with over 8 people per day. Almost 20% of social interactions were entirely positive, while 10% were entirely negative. Social support did not correlate with MEBO symptoms and it was not predictor nor protective of malodor.

Graphs of depressive feelings vs odors is another prove that even with stress as a trigger, body odors are not all in your head. Obviously, those free of malodors tend to be happier, but it's possible to control depression even with worst MEBO symptoms and happy mood, alone, does not help to control the symptoms.

uBiome provides a multitude of measurements characterizing gut microbiomes. One of the most widely used metrics is gut diversity metrics.

Microbial diversity is cornerstone of a good health and decreased diversity is likely to be associated with poor wellbeing including malodors. Our data, however, show that most MEBO volunteers have healthy diversity scores that do not correlate with incidence of odors. Correlation is observed only for  cases of very low, unhealthy diversity, especially for total quality of life scores as opposed to just malodor symptoms. Even more so, MEBO volunteers in remission, completely free of odors, had healthy,  but not the very best diversity scores.

In extremely diverse communities, people may be less inclined to trust each other, vote and volunteer for activities. In people not suffering from uncontrollable odors, microbes and hosts have a balanced dialogue, and form symbiotic relationships beneficial for both parties.

Could it be that MEBO sufferers have more "smelly" bacteria and less bacteria neutralizing the smell?  Levels of traditional probiotic strains in the study participants do not seem to correlate with their odor levels. As more data is accumulated, interesting patterns are emerging for less common bacteria. An example is Anaerovorax, bacterium that processes putrid-smelling compounds produced by clostridia, pseudomonads, lactic acid and other bacteria from amino acids in food. Anaerovorax is observed in only 3% of uBiome samples, but it is present in a quarter of MEBO participants. Plotting its levels in all samples with Anaerovorax present against the scores representing improvement of MEBO symptoms (from worst odor to no odor), shows a clear trendline - the more Anaerovorax, the less odor. We note that this seem to be the case for ONLY a subset of study participants. For example, participants #901298 and #901240 who contributed 2 samples each into the first 41-sample-set, had 0 Anaerovorax on their worse day and over 0.03% Anaerovorax on their better days. # 901240 submitted 2 "bad day" samples (which is perfectly fine - as it still yielded much needed data!) had a little more Anaerovorax on a slightly better day. #90346 had experienced exactly the same MEBO symptoms on both days of sampling, but the result with 0 Anaerovorax corresponded to a worse Quality of Life score. #90365 experienced exactly the same symptoms for days with and without Anaerovorax, and had the same Quality of Life Score, but there was a noticeable difference in diet. This person had more Anaerovorax when consumed more odor triggers in food (onions and vinegar).

There is not much known about the role of Anaerovorax in human gut. It is proposed to increase when adding meat to a usually vegetarian diet and with increased fasting insulin levels. It is also increased in healthy preadolescent children (7 to 12 years old) and by minerals such as Zinc and Manganese.

Levels of TMA-producing bacteria such as Desulfibrio and Bacteroides seem to lower when odor levels are decreasing in most cases, although signal-to-noise ratio is weak and the dependence is very individual (see Figure). The trend is similar for #901214, #90265, #900841 and #901273. #901253 is one of the outliers: MEBO symptoms in this case were improving with higher levels of Bacteroides and lover diversity (and a much stricter diet).

Bacteroides maintain a complex and generally beneficial relationship with the host. The genus Bacteroides makes up to 30% of the bacteria in the human gut. Levels of Bacteroides increase with rapid weight loss. Specific species of Bacteroides, have a role in preventing infection with Clostridium difficile. Level of Bacteroides, however, increase (or significantly decrease) in inflammatory bowel disease and chronic fatigue syndrome.
Lactobacillus and bifidobacteria probiotics, garlic, walnuts and barley could all decrease levels of Bacteroides. Polydextrose (dietary fiber found in traditional bakery items, beverages, dairy products and sauces) not only decreases Bacteroides but also increases probiotic strains of Lactobacillus and Bifidobacterium.

These are only preliminary results. We'll be looking at more complex patterns in bacterial community structures associated with different subgroups of study participants. We'll be posting new findings as we mine more data and get additional results.

If you have not started the study yet, we hope that this post encourages you to start participating. As you see, every data point counts, even if the results of your experimentation and odor reduction approaches are not as good as we wished.


REFERENCES


Vemuri R, Gundamaraju R, Shastri MD, Shukla SD, Kalpurath K, Ball M, Tristram S, Shankar EM, Ahuja K, Eri R. Gut Microbial Changes, Interactions, and Their Implications on Human Lifecycle: An Ageing Perspective. BioMed research international. 2018;2018.

Zhang Q, Xiao X, Li M, Yu M, Ping F, Zheng J, Wang T, Wang X. Vildagliptin increases butyrate-producing bacteria in the gut of diabetic rats. PloS one. 2017 Oct 16;12(10):e0184735.

Roeder J, Schink B. Syntrophic degradation of cadaverine by a defined methanogenic coculture. Applied and environmental microbiology. 2009 Jul 15;75(14):4821-8.

Lau SK, Teng JL, Chiu TH, Chan E, Tsang AK, Panagiotou G, Zhai SL, Woo PC. Differential Microbial Communities of Omnivorous and Herbivorous Cattle in Southern China. Computational and structural biotechnology journal. 2018 Jan 1;16:54-60.

Filocamo A, Nueno-Palop C, Bisignano C, Mandalari G, Narbad A. Effect of garlic powder on the growth of commensal bacteria from the gastrointestinal tract. Phytomedicine. 2012 Jun 15;19(8-9):707-11.

Cruden DL, Galask RP. Reduction of trimethylamine oxide to trimethylamine by Mobiluncus strains isolated from patients with bacterial vaginosis. Microbial Ecology in Health and Disease. 1988 Jan 1;1(2):95-100.

Craciun S, Balskus EP. Microbial conversion of choline to trimethylamine requires a glycyl radical enzyme. Proceedings of the National Academy of Sciences. 2012 Dec 26;109(52):21307-12.

Sunday, July 1, 2018

Consentimiento de investigaci贸n para el estudio MEBO Microbiome

sitios seguros de htpps:   MEBO Microbioma    Prueba de calidad de vida


Estudio de investigaci贸n: Din谩mica de la microbiota intestinal en la producci贸n idiop谩tica del mal olor


● Estar en un estudio es voluntario: tu elecci贸n.
● Si se une a este estudio, puede detenerse en cualquier momento.
● Nadie puede prometerle que un estudio lo ayudar谩.
● No se una a este estudio a menos que se respondan todas sus preguntas.



Antes de decidir si participa en este estudio de investigaci贸n, debe revisar:

1. El prop贸sito del estudio de investigaci贸n
2. Los procedimientos de estudio
3. Cu谩nto durar谩 su participaci贸n en la investigaci贸n
4. Cualquier procedimiento que sea experimental


5. Cualquier riesgo razonablemente previsible, incomodidades y beneficios de la investigaci贸n
6. Cualquier procedimiento o tratamiento alternativo potencialmente beneficioso
7. C贸mo se mantendr谩 la confidencialidad de sus datos
8. La posibilidad de riesgos imprevisibles
9. Cualquier costo adicional para ti


10. Qu茅 sucede si decide dejar de participar
11. Nuevos hallazgos que pueden afectar su deseo de participar
12. Cu谩ntas personas estar谩n en el estudio

Introducci贸n



MEBO Research, Inc., ("MEBO") es una campa帽a internacional de defensa del paciente fundada por el paciente registrada en el Estado de Florida, EE. UU., Desde el 21 de abril de 2010, seg煤n la secci贸n 501 (c) (3) del C贸digo de Rentas Internas, clasificada como empresa p煤blica de beneficencia.  MEBO Research tambi茅n est谩 registrada en Inglaterra y Gales como una empresa sin 谩nimo de lucro, limitada por garant铆a (2009). MEBO es un miembro de la organizaci贸n NORD y EURORDIS y sus directores son moderadores de la comunidad Trimethylaminuria en RareConnect.org. MEBO se menciona como una organizaci贸n de apoyo y defensa en sitios web como Genetic Alliance y Orphanet.



MEBO significa olor corporal metab贸lico e incluye olor corporal sist茅mico, mal aliento y episodios continuos de mal olor NO relacionados con la higiene o el exceso de gases. PATM denota la condici贸n "Personas al茅rgicas a m铆" ("People Allergic to me" .

PROP脫SITO DE LA INVESTIGACI脫N

Est谩 invitado a participar en un estudio de investigaci贸n sobre din谩mica microbiana en condiciones MEBO y PATM. Esperamos aprender qu茅 comunidades microbianas est谩n asociadas con los brotes y las remisiones de estas afecciones y las mejores formas de reducir los s铆ntomas.

Usted fue seleccionado como posible participante en este estudio porque demostr贸 buenas habilidades de comunicaci贸n y disposici贸n para seguir reg铆menes alimentarios nutricionalmente equilibrados y contribuir con datos de seguimiento de resultados.



Si decide cancelar su participaci贸n en este estudio, debe notificar a Mar铆a de la Torre a maria.delatorre@meboresearch.org

Este estudio de investigaci贸n est谩 buscando hasta 100 personas con todas las manifestaciones de mal olor corporal, halitosis y / o PATM. Esperamos inscribir a los participantes del estudio de investigaci贸n en todos los Estados Unidos e internacionalmente.

PARTICIPACION VOLUNTARIA

Su participaci贸n en este estudio es completamente voluntaria. Su decisi贸n de no participar no tendr谩 ning煤n efecto negativo en usted ni en su atenci贸n m茅dica. Puede decidir participar ahora o retirar su consentimiento en cualquier momento durante el proceso de estudio sin ninguna p茅rdida de beneficios o atenci贸n m茅dica a la que pueda tener derecho, si corresponde.
DURACI脫N DE LA PARTICIPACI脫N DEL ESTUDIO

Se espera que este estudio de investigaci贸n tome aproximadamente un a帽o.


PROCEDIMIENTOS

Si decide participar, la Directora de Protocolo, Irene Gabashvili, PhD, y su personal de estudio de investigaci贸n, Mar铆a de la Torre abordar谩 todos los asuntos relacionados con este proceso de investigaci贸n con usted por escrito y por correo electr贸nico a la direcci贸n de correo electr贸nico que proporcione. Su respuesta formal a dichas comunicaciones tambi茅n deber谩 ser por escrito por correo electr贸nico. De esta manera, se presentar谩n instrucciones claras, cuadros, gr谩ficos, resultados, calendario y sus comentarios de manera ordenada. 

Ninguna de las encuestas u otros procedimientos utilizados por los investigadores en este estudio de investigaci贸n son invasivos o experimentales. Los procedimientos involucrados no implican riesgos significativos, y no hay compensaci贸n o tratamiento disponible si la lesi贸n ocurre como resultado de la participaci贸n. Los hisopos y otros materiales utilizados para la recolecci贸n de muestras se esterilizan antes del env铆o y se deben manipular con el cuidado e higiene adecuados. Si no se siente c贸modo manipulando el kit de recolecci贸n y aceptando la responsabilidad de su uso, reconsidere su participaci贸n en este estudio.

Le pedimos que tome muestras con tres kits de uBiome para an谩lisis de microbioma intestinal y complete este cuestionario:




Estos cuadros describen cu谩ndo puede recolectar las tres muestras dependiendo de si su condici贸n est谩 en estado activo o en remisi贸n:











Cuando est茅 listo para comenzar a tomar muestras, siga las instrucciones a continuaci贸n para recolectar su muestra:




Si desea, puede responder preguntas de uBiome sobre su tipo de heces, s铆ntomas abdominales,
Despu茅s de que devuelva su muestra a trav茅s del correo prepago, su informe de prueba uBiome Explorer estar谩 disponible a trav茅s de su portal para pacientes aproximadamente 6 semanas despu茅s. Tambi茅n recibir谩 un correo electr贸nico notific谩ndole que sus resultados est谩n listos.

Cualquiera de sus muestras que se utilizan en la investigaci贸n puede dar como resultado nuevos productos, pruebas o descubrimientos. En algunos casos, estos pueden tener un valor comercial potencial y pueden ser desarrollados y ser propiedad de uBiome u otros. Nuestro acuerdo con Ubiome les permite presentar cualquier patente relacionada con los resultados de las pruebas. Sin embargo, los donantes de muestras no retienen ning煤n derecho de propiedad sobre los materiales. Por lo tanto, no compartir铆a ning煤n beneficio financiero de estos productos, pruebas o descubrimientos.


Los resultados del estudio de sus muestras de este proyecto se utilizar谩n solo con fines de investigaci贸n. En cuanto a informarle sobre los resultados de la prueba, debe comprender lo siguiente:

·       La informaci贸n puede ser demasiado limitada para darle detalles o consecuencias particulares;

La informaci贸n de los an谩lisis de sus muestras codificadas y su informaci贸n m茅dica codificada se colocar谩 en una de las bases de datos de los Institutos Nacionales de Salud (NIH) junto con la informaci贸n de los otros participantes de la investigaci贸n y se utilizar谩 para futuras investigaciones. Estas bases de datos ser谩n accesibles por Internet. Solo la informaci贸n an贸nima de los an谩lisis se colocar谩 en una base de datos completamente p煤blica, disponible para cualquier persona en Internet.

No se colocar谩 en la base de datos p煤blica ninguna informaci贸n de identificaci贸n utilizada tradicionalmente sobre usted, como su nombre, direcci贸n, n煤mero de tel茅fono o n煤mero de seguro social. Si bien la base de datos p煤blica no contendr谩 informaci贸n que se usa tradicionalmente para identificarlo, las personas pueden desarrollar formas en el futuro que permitan que alguien vincule su informaci贸n m茅dica en nuestras bases de datos. Por ejemplo, alguien podr铆a comparar informaci贸n en nuestras bases de datos con informaci贸n suya (o un familiar de sangre) en otra base de datos y ser capaz de identificarlo a usted (o a su pariente consangu铆neo). Tambi茅n es posible que haya violaciones a la seguridad de los sistemas inform谩ticos utilizados para almacenar los c贸digos que relacionan su informaci贸n gen茅tica y m茅dica con usted. 

Sin embargo, su privacidad es muy importante para nosotros y utilizaremos medidas de seguridad para protegerla. A pesar de todas las medidas de seguridad que utilizaremos, no podemos garantizar que su identidad nunca se conozca.



RESPONSABILIDADES DE LOS PARTICIPANTES


Como participante, sus responsabilidades incluyen:

·       Seguir las instrucciones del Director del Protocolo y del personal del estudio.
·       Informe al Director de Protocolo o al personal del estudio de investigaci贸n sobre cualquier efecto secundario, visita al m茅dico u hospitalizaci贸n que pueda tener.
·       Guarde sus diarios seg煤n las instrucciones.
·       Complete sus cuestionarios seg煤n las instrucciones.
·       Haga preguntas mientras piensa en ellas.
·       D铆gale al Director de Protocolo o al personal de investigaci贸n si cambia de opini贸n acerca de permanecer en el estudio.


RETIRADA DEL ESTUDIO

Si primero acepta participar y luego cambia de opini贸n, puede retirar su consentimiento y suspender su participaci贸n en cualquier momento. Su decisi贸n no afectar谩 su capacidad de recibir atenci贸n m茅dica para su enfermedad y no perder谩 ning煤n beneficio al que de otra manera tendr铆a derecho.

Si decide retirar su consentimiento para participar en este estudio, debe notificar a Mar铆a de la Torre a maria.delatorre@meboresearch.org.


    POSIBLES RIESGOS, MOLESTIAS E INCONVENIENTES

    Existen riesgos, incomodidades e inconvenientes asociados con cualquier estudio de investigaci贸n. Estos merecen una reflexi贸n cuidadosa. Deber铆a hablar con el Director de Protocolo si tiene alguna pregunta.

    • Algunas preguntas de la encuesta pueden hacer que usted los miembros de su familia se sientan inc贸modos.


    • Sus datos, respuestas de la encuesta y / o informaci贸n de identificaci贸n personal pueden verse comprometidos en caso de incumplimiento de la seguridad o incumplimiento del protocolo. En caso de incumplimiento, si sus datos est谩n asociados con su identidad, pueden hacerse p煤blicos y pueden tener consecuencias sociales y psicol贸gicas para usted o sus seres queridos.


    • Cuando los investigadores publican los resultados de este estudio, su informaci贸n puede incluirse en res煤menes agrupados que se hacen p煤blicos. La identificaci贸n de sus datos a nivel individual de esos res煤menes ser铆a extremadamente dif铆cil, pero es posible que un tercero que haya obtenido datos parciales de usted pueda comparar sus datos parciales con los resultados publicados y determinar indirectamente algunas de las respuestas de su encuesta


    • Si bien la informaci贸n que guardamos no incluye nombres, y el microbioma no es identificable de manera 煤nica, la informaci贸n gen茅tica humana es 煤nica y se puede utilizar para identificar personas al vincular o rastrear ADN en bases de datos p煤blicas.


    • Al igual que con cualquier servicio en l铆nea, si divulga la contrase帽a de su cuenta a otras personas, es posible que puedan acceder a su cuenta y a su informaci贸n. Puede haber riesgos adicionales para la participaci贸n que actualmente son imprevisibles.

    BENEFICIOS POTENCIALES

    No podemos  garantizar ni prometemos que recibir谩 alg煤n beneficio de este estudio.


    ALTERNATIVAS

    La alternativa es no participar en este estudio.

    DERECHOS DEL PARTICIPANTE

    No debe sentirse obligado a aceptar participar. Sus preguntas deben responderse claramente y para su satisfacci贸n. Si decide no participar, d铆gaselo al Director del Protocolo.

    Se le informar谩 sobre cualquier nueva informaci贸n importante que se aprenda durante el curso de este estudio de investigaci贸n, lo que podr铆a afectar su condici贸n o su deseo de continuar participando en este estudio.

    ClinicalTrials.gov

    Una descripci贸n de este ensayo cl铆nico estar谩 disponible en http://www.ClinicalTrials.gov, seg煤n lo exige la ley de los EE. UU. Este sitio web no incluir谩 informaci贸n que pueda identificarlo. Como m谩ximo, el sitio web incluir谩 un resumen de los resultados. Puede buscar este sitio web en cualquier momento. 

    Una descripci贸n de este ensayo cl铆nico est谩 disponible en https://clinicaltrials.gov ct2/show/NCT03582826, seg煤n lo exige la ley de los EE. UU.  Este sitio web no incluir谩 informaci贸n que pueda identificarlo.  Como m谩ximo, el sitio web incluir谩 un resumen de los resultados.  Puede buscar este sitio web en cualquier momento. 


    CONFIDENCIALIDAD

    Los resultados de este estudio de investigaci贸n pueden presentarse en reuniones cient铆ficas o m茅dicas o publicarse en revistas cient铆ficas. Su identidad y / o su informaci贸n personal de salud no se divulgar谩n a menos que lo autorice o lo exija la ley. Sin embargo, siempre existe el riesgo de que incluso la informaci贸n no identificada pueda volver a identificarse.

    La informaci贸n del paciente se puede proporcionar a las agencias reguladoras federales y otras seg煤n se requiera. La Administraci贸n de Alimentos y Medicamentos (FDA), por ejemplo, puede inspeccionar los registros de investigaci贸n y conocer su identidad si este estudio cae dentro de su jurisdicci贸n.



    Autorizaci贸n para usar su informaci贸n de salud con fines de investigaci贸n

    Debido a que la informaci贸n sobre usted y su salud es personal y privada, generalmente no se puede utilizar en este estudio de investigaci贸n sin su autorizaci贸n por escrito. Si firma este formulario, proporcionar谩 esa autorizaci贸n. El formulario est谩 destinado a informarle sobre c贸mo se usar谩 o divulgar谩 su informaci贸n de salud en el estudio. Su informaci贸n solo ser谩 utilizada de acuerdo con este formulario de autorizaci贸n y el formulario de consentimiento informado y seg煤n lo requiera o permita la ley. Por favor l茅elo detenidamente antes de firmarlo.

    ¿Cu谩l es el prop贸sito de este estudio de investigaci贸n y c贸mo se utilizar谩 mi informaci贸n de salud en el estudio?

    El prop贸sito de este estudio es conocer qu茅 comunidades microbianas est谩n asociadas con brotes y remisiones de mal olor y condiciones de PATM. La informaci贸n de alguna forma se enviar谩 al patrocinador, uBiome. Su informaci贸n no identificada puede incluirse en res煤menes agrupados cuando los investigadores publican los resultados de este estudio. 



    ¿Debo firmar este formulario de autorizaci贸n?


    No es necesario que firme este formulario de autorizaci贸n. Pero si no lo hace, no podr谩 participar en este estudio de investigaci贸n. Firmar el formulario no es una condici贸n para recibir atenci贸n m茅dica fuera del estudio.

    Si firmo, ¿puedo revocarlo o retirarme de la investigaci贸n m谩s tarde?


    Si decide participar, puede retirar su autorizaci贸n con respecto al uso y la divulgaci贸n de su informaci贸n de salud (y suspender cualquier otra participaci贸n en el estudio) en cualquier momento. Despu茅s de cualquier revocaci贸n, su maria.delatorre@meboresearch.org

    ¿Qu茅 informaci贸n personal se obtendr谩, utilizar谩 o divulgar谩?


    Su informaci贸n de salud relacionada con este estudio se puede usar o divulgar en conexi贸n con este estudio de investigaci贸n, que incluye, entre otros, la gravedad de sus s铆ntomas y los resultados de las pruebas de laboratorio.


    ¿Qui茅n puede usar o divulgar la informaci贸n?

    Las siguientes partes est谩n autorizadas a usar y / o divulgar su informaci贸n de salud en relaci贸n con este estudio de investigaci贸n:
    ·        El Director del Protocolo (Irene Gabashvili)
    ·        Personal investigador (Maria de la Torre)


    ¿Qui茅n puede recibir o usar la informaci贸n?

    Las partes enumeradas en el p谩rrafo anterior pueden divulgar su informaci贸n de salud a las siguientes personas y organizaciones para su uso en relaci贸n con este estudio de investigaci贸n:

    ·        La Oficina de Protecci贸n de Investigaciones Humanas en el Departamento de Salud y Servicios Humanos de EE. UU.

    ¿Cu谩ndo caducar谩 mi autorizaci贸n?

    Su autorizaci贸n para el uso y / o divulgaci贸n de su informaci贸n m茅dica finalizar谩 el 31 de diciembre de 2019 o cuando finalice el proyecto de investigaci贸n, lo que ocurra primero.

    ¿El acceso a mi historial m茅dico ser谩 limitado durante el estudio?

    Para mantener la integridad de este estudio de investigaci贸n, es posible que no tenga acceso a ninguna informaci贸n de salud desarrollada como parte de este estudio hasta que se complete. En ese momento, tendr谩 acceso a dicha informaci贸n de salud si fue utilizada para tomar una decisi贸n m茅dica o de facturaci贸n sobre usted (por ejemplo, si est谩 incluida en su registro m茅dico oficial).

    CONSIDERACIONES FINANCIERAS

    Pago / reembolso

    No se le pagar谩 para participar en este estudio de investigaci贸n.

                                                                                    
    Costos

    No hay ning煤n costo para usted por participar en este estudio, aparte de los gastos b谩sicos como el uso de Internet y el tiempo personal que le llevar谩 completar los cuestionarios.

    Se les puede pedir a los participantes internacionales que donen a MEBO Research para compensar parcialmente los costos de env铆o.

    Patrocinador

    uBiome y MEBO Research brindan apoyo financiero y / o material para este estudio. uBiome est谩 respaldando las pruebas de microbioma y el an谩lisis parcial de los resultados, y los costos de env铆o internos. MEBO Research cubrir谩 los costos de env铆o internacionales.


    COMPENSACI脫N por lesiones relacionadas con la investigaci贸n


    Todas las formas de diagn贸stico y tratamiento m茅dicos, ya sean de rutina o experimentales, implican cierto riesgo de lesi贸n. A pesar de todas las precauciones, es posible que desarrolle complicaciones m茅dicas al participar en este estudio. Si surgen tales complicaciones, el Director del Protocolo y el personal del estudio de investigaci贸n lo ayudar谩n a obtener el tratamiento m茅dico adecuado. En el caso de que tenga una lesi贸n o enfermedad causada directamente por su participaci贸n en este estudio, se solicitar谩 primero el reembolso de todos los costos relacionados de la atenci贸n de su aseguradora, plan de atenci贸n administrada u otro programa de beneficios. Usted ser谩 responsable de cualquier copago o deducible asociado seg煤n lo requiera su seguro.
    Si los costos de la atenci贸n relacionados con dicha lesi贸n no est谩n cubiertos por su aseguradora, plan de atenci贸n administrada u otro programa de beneficios, usted puede ser responsable de estos costos. Si no puede pagar dichos costos, el Director de Protocolo lo ayudar谩 a solicitar los beneficios suplementarios y le explicar谩 c贸mo solicitar la asistencia financiera del paciente en el hospital.

    Usted no renuncia a ning煤n derecho de responsabilidad por da帽os personales al firmar este formulario.


    INFORMACI脫N DEL CONTACTO

    Preguntas, inquietudes o quejas: si tiene alguna pregunta, inquietud o queja sobre este estudio de investigaci贸n, sus procedimientos, riesgos y beneficios, o cursos alternativos de tratamiento, debe preguntar al Director del Protocolo.
    Notificaci贸n de lesiones: si siente que ha sido lastimado por ser parte de este estudio, comun铆quese con el Director del Protocolo o el Personal de Investigaci贸n.

    Contacto independiente: si no est谩 satisfecho con la forma en que se realiza este estudio, o si tiene inquietudes, quejas o preguntas generales sobre la investigaci贸n o sus derechos como participante, comun铆quese con la Junta de Revisi贸n Institucional (IRB) de MEBO para hablar a alguien independiente del equipo de investigaci贸n en mike@meboresearch.org

    Contacto alternativo: si no puede comunicarse con el Director de protocolo, comun铆quese con Maria de la Torre a maria.delatorre@meboresearch.org

    Preguntas, inquietudes o quejas: si tiene alguna pregunta, inquietud o queja sobre este estudio de investigaci贸n, sus procedimientos, riesgos y beneficios, o cursos de tratamiento alternativos, debe preguntarle a la directora de protocolo, Irene Gabashvili, en irene.gabashvili@meboresearch.org. Tambi茅n debe contactarla en cualquier momento si siente que ha sido lastimado por ser parte de este estudio.


    DERECHOS DEL SUJETO EXPERIMENTAL


    Como participante de la investigaci贸n, tiene los siguientes derechos. Estos derechos incluyen, entre otros, el derecho del participante a:

    DERECHOS DEL SUJETO EXPERIMENTAL
    Como participante de la investigaci贸n, tiene los siguientes derechos. Estos derechos incluyen, entre otros, el derecho del participante a:

    • estar informado de la naturaleza y el prop贸sito del experimento;
    • recibir una explicaci贸n de los procedimientos a seguir en el experimento m茅dico y de cualquier droga o dispositivo a ser utilizado;
    • se le dar谩 una descripci贸n de las incomodidades y riesgos concomitantes que puedan esperarse razonablemente;
    • recibir una explicaci贸n de los beneficios que razonablemente se pueden esperar del sujeto, si corresponde;
    • recibir una divulgaci贸n de las alternativas, medicamentos o dispositivos apropiados que puedan ser ventajosos para el sujeto, sus riesgos y beneficios relativos;
    • ser informado de las v铆as de tratamiento m茅dico, si hay disponibles para el sujeto despu茅s del experimento si surgen complicaciones;
    • tener la oportunidad de hacer preguntas sobre el experimento o los procedimientos involucrados;
    • ser instruido que el consentimiento para participar en el experimento m茅dico puede ser retirado en cualquier momento y el sujeto puede descontinuar la participaci贸n sin prejuicios;
    • recibir una copia del formulario de consentimiento firmado y fechado; 
    • se le dar谩 la oportunidad de decidir dar su consentimiento o no a un experimento m茅dico sin la intervenci贸n de ning煤n elemento de fuerza, fraude, enga帽o, coacci贸n, coacci贸n o influencia indebida en la decisi贸n del sujeto.