Showing posts with label malodor. Show all posts
Showing posts with label malodor. Show all posts

Thursday, August 29, 2019

Reducing the stigma of odor disorders

Some conditions - such as obesity, depression and functional odor disorders - come with a social stigma. Understanding the etiology of these conditions helps to avoid stereotypes and find remedies. 

Metabolomics analysis of morning urine samples helped to evaluate the heterogeneity of MEBO population as good as challenge tests, procedures used to induce symptoms and assess resilience to perturbations caused by sugars. 


...  Read more ... 

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.

Friday, June 15, 2018

Research Consent for the ongoing MEBO Microbiome study

secure htpps sites:       MEBO Microbiome                Life Quality Test


Research study: Dynamics of the Gut Microbiota in Idiopathic Malodor Production


● Being in a study is voluntary – your choice.
● If you join this study, you can still stop at any time.
● No one can promise that a study will help you.
● Do not join this study unless all of your questions are answered.


Before you decide whether to participate in this research studyyou should review:

1.     The purpose othe research study
2.     The study procedures
3.     How long your involvement in the research willast
4.     Any procedures thaare experimental
5.     Any reasonably foreseeable risks, discomforts, and benefits othe research
6.     Any potentially beneficial alternative procedures otreatments
7.     How the confidentiality of your data will be maintained
8.     The possibility of unforeseeable risks
9.      Any added costs to you
10.     What happens if you decide to stop participating
11.     New findings thamay affect your willingness to participate
12.     How many people will be in the study


Introduction


MEBO Research, Inc.(“MEBO”) is a sufferer-founded patient advocacy international campaign registered in the State of Florida, U.S., since April 21, 2010, under section 501(c)(3) of the Internal Revenue Code, classification of Public Charity. MEBO Research is also registered in England and Wales as a Not For Profit, Limited by Guarantee Company (2009). MEBO is a NORD and EURORDIS Organization Member and its directors are moderators of the Trimethylaminuria Community at RareConnect.org. MEBO is referenced as an Advocacy and Support Organization in websites like the Genetic Alliance and Orphanet.

MEBO means metabolic body odor and it includes systemic body odor, bad breath and continuing episodes of malodor NOT related to hygiene or excessive gas. PATM denotes "People Allergic To Me" condition.

PURPOSE OF RESEARCH

You are invited to participate in a research study of microbial dynamics in MEBO and PATM conditions.  We hope to learn what microbial communities are associated with flare ups and remissions of these conditions and best ways to reduce the symptoms. 

You were selected as a possible participant in this study because you demonstrated good communication skills and willingness to follow nutritionally balanced dietary regimes and contribute follow-up outcome data.

If you decide to terminate your participation in this study, you should notify Maria de la Torre at maria.delatorre@meboresearch.org 

This research study is looking for up to 100 people with all manifestations of body malodor, halitosis and/or PATM. We expect to enroll research study participants, throughout the United States and internationally.

VOLUNTARY PARTICIPATION

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now or withdraw your consent at any time throughout the study process without any loss of benefits or medical care to which you may be entitled, if any.

DURATION OF STUDY INVOLVEMENT

This research study is expected to take approximately one year.  


PROCEDURES

If you choose to participate, the Protocol Director, Irene Gabashvili, PhD, and her research study staff, Maria de la Torre will address all matters regarding this research process with you in writing via email to the email address you provide. Your formal reply to said communications will also need to be in writing via email.  In this manner, clear instructions, charts, graphs, results, calendar, and your feedback will be presented in an orderly manner. 

None of the surveys or other procedures used by the investigators in this Research study are invasive or experimental. The procedures involved do not involve significant risks, and no compensation or treatment is available if injury occurs as a result of participation. Swabs and other materials used for sample collection are sterilized prior to shipment and must be handled with proper care and hygiene. Should you be uncomfortable handling the collection kit and accepting responsibility for its use, please reconsider your participation in this study.

We are asking you to self-sample with three uBiome gut microbiome kits and fill in this questionnaire:





These charts describe when you could collect the three samples depending if your condition is in active state or in remission:












When you are ready to begin sampling, follow the instructions below to collect your sample:

















You may also want to answer uBiome questions about your stool type, symptoms and wellbeing. 
  
After you return your sample via the prepaid mailer, your uBiome Explorer test report will be available via your patient portal approximately 6 weeks later. You will also receive an email notifying you that your results are ready.



Any of your samples which are used in research may result in new products, tests or discoveries. In some instances, these may have potential commercial value and may be developed and owned by uBiome or others. Our agreement with Ubiome allows them to file any patents relating to test results. However, donors of samples do not retain any property rights to the materials.  Therefore, you would not share in any financial benefits from these products, tests or discoveries.


The results of the study of your samples from this project will be used for research purposes only. Regarding informing you of the test results, you should understand the following:
·       The information may be too limited to give you particular details or consequences;

Information from analyses of your coded samples and your coded medical information will be put into one of the National Institutes of Health (NIH) databases along with information from the other research participants and will be used for future research. These databases will be accessible by the Internet. Only anonymous information from the analyses will be put in a completely public database, available to anyone on the Internet.

No traditionally-used identifying information about you, such as your name, address, telephone number, or social security number, will be put into the public database. While the public database will not contain information that is traditionally used to identify you, people may develop ways in the future that would allow someone to link your medical information in our databases back to you. For example, someone could compare information in our databases with information from you (or a blood relative) in another database and be able to identify you (or your blood relative). It also is possible that there could be violations to the security of the computer systems used to store the codes linking your genetic and medical information to you.

However, your privacy is very important to us and we will use safety measures to protect it. Despite all of the safety measures that we will use, we cannot guarantee that your identity will never become known.


PARTICIPANT RESPONSIBILITIES


As a participant, your responsibilities include: 

·       Follow the instructions of the Protocol Director and study staff.
·       Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.
·       Keep your diaries as instructed.
·       Complete your questionnaires as instructed.
·       Ask questions as you think of them.
·       Tell the Protocol Director or research staff if you change your mind about staying in the study.
·       Destroy or return any unused tests kits to uBiome.  


WITHDRAWAL FROM STUDY

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time.  Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled.

If you decide to withdraw your consent to participate in this study, you should notify Maria de la Torre at maria.delatorre@meboresearch.org

You should destroy or return any unused test kits or other materials to uBiome at the completion or earlier termination of this study

    POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES

    There are risks, discomforts, and inconveniences associated with any research study.  These deserve careful thought.  You should talk with the Protocol Director if you have any questions.

    • Some survey questions may make you or your family members uncomfortable. 

    • Your data, survey responses, and/or personally identifying information may be compromised in the event of a security breach or failure to follow protocol. In the event of such a breach, if your data are associated with your identity, they may be made public and it may have social and psychological consequences for you or your loved ones. 

    • When investigators publish results from this study, your information may be included within pooled summaries that are made public. Identification of your individual-level data from those summaries would be extremely difficult, but it is possible that a third party that has obtained partial data from you could compare their partial data to the published results and indirectly determine some of your survey responses. 

    • While the information we keep will not include names, and the microbiome is not uniquely identifiable, human genetic information is unique and can be used to identify people by linking or tracing DNA in public databases. 

    • As with any online service, if you disclose your account password to others, they may be able to access your account and your information. There may be additional risks to participation that are currently unforeseeable.


    POTENTIAL BENEFITS

    We cannot and do not guarantee or promise that you will receive any benefits from this study.



    ALTERNATIVES



    The alternative is not to participate in this study.



    PARTICIPANT’S RIGHTS



    You should not feel obligated to agree to participate.  Your questions should be answered clearly and to your satisfaction.  If you decide not to participate, tell the Protocol Director. 



    You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.



    ClinicalTrials.gov



     A description of this clinical trial will be available on http://www.ClinicalTrials.govas required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time.




    CONFIDENTIALITY



    The results of this research study may be presented at scientific or medical meetings or published in scientific journals.  Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law However, there is always some risk that even de-identified information might be re-identified.



    Patient information may be provided to Federal and other regulatory agencies as required.  The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.






    Authorization To Use Your Health Information For Research Purposes 



    Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization.  If you sign this form, it will provide that authorization.  The form is intended to inform you about how your health information will be used or disclosed in the study.  Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law.  Please read it carefully before signing it. 



    What is the purpose of this research study and how will my health information be utilized in the study?

    The purpose of this study is to learn what microbial communities are associated with flare ups and remissions of malodor and PATM conditions. The information in some form will be submitted to the sponsor, uBiome. Your de-identified information may be included within pooled summaries when investigators publish results from this study. 





    Do I have to sign this authorization form?

    You do not have to sign this authorization form.  But if you do not, you will not be able to participate in this research study. Signing the form is not a condition for receiving any medical care outside the study.



    If I sign, can I revoke it or withdraw from the research later?

    If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time.  After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research).  If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to Irene Gabashvili at irene.gabashvili@meboresearch.org



    What Personal Information Will Be Obtained, Used or Disclosed?

    Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to severity of your symptoms and laboratory test results. 


    Who May Use or Disclose the Information?
    The following parties are authorized to use and/or disclose your health information in connection with this research study:
    ·        The Protocol Director (Irene Gabashvili)
    ·        Research Staff (Maria de la Torre)


    Who May Receive or Use the Information?
    The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:

    ·        The Office for Human Research Protections in the U.S. Department of Health and Human Services


    When will my authorization expire?
    Your authorization for the use and/or disclosure of your health information will end on December 31, 2019 or when the research project ends, whichever is earlier.

    Will access to my medical record be limited during the study?
    To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed.  At that point, you would have access to such health information if it was used to make a medical or billing decision about you (e.g., if included in your official medical record).

    FINANCIAL CONSIDERATIONS

    Payment/Reimbursement

    You will not be paid to participate in this research study.
                                                                                    
    Costs
    There is no cost to you for participating in this study, other than basic expenses like Internet usage and the personal time it will take to fill in the questionnaires.

    International participants may be asked to donate to MEBO Research to partially compensate for shipping costs. 

    Sponsor

    uBiome and MEBO Research are providing financial support and/or material for this study. uBiome is supporting microbiome testing and partial analysis of the results, and domestic shipping costs. MEBO Research will be covering International shipping costs.


    COMPENSATION for Research-Related Injury


    All forms of medical diagnosis and treatment – whether routine or experimental – involve some risk of injury.  In spite of all precautions, you might develop medical complications from participating in this study.  If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment.  In the event that you have an injury or illness that is directly caused by your participation in this study, reimbursement for all related costs of care first will be sought from your insurer, managed care plan, or other benefits program.  You will be responsible for any associated co-payments or deductibles as required by your insurance.

    If costs of care related to such an injury are not covered by your insurer, managed care plan or other benefits program, you may be responsible for these costs.  If you are unable to pay for such costs, the Protocol Director will assist you in applying for supplemental benefits and explain how to apply for patient financial assistance from the hospital.

    You do not waive any liability rights for personal injury by signing this form.

    CONTACT INFORMATION

    Questions, Concerns, or Complaints:  If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the Protocol Director.

    Injury Notification:  If you feel you have been hurt by being a part of this study, please contact the Protocol Director or Research Staff.

    Independent Contact:  If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the MEBO Institutional Review Board (IRB) to speak to someone independent of the research team at mike@meboresearch.org


    Alternate Contact:  If you cannot reach the Protocol Director, please contact Maria de la Torre at maria.delatorre@meboresearch.org 

    Questions, Concerns, or Complaints:  If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the Protocol Director, Irene Gabashvili at irene.gabashvili@meboresearch.org.  You should also contact her at any time if you feel you have been hurt by being a part of this study.

    EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

    As a research participant you have the following rights.  These rights include but are not limited to the participant's right to:
    • be informed of the nature and purpose of the experiment;
    • be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized;
    • be given a description of any attendant discomforts and risks reasonably to be expected;
    • be given an explanation of any benefits to the subject reasonably to be expected, if applicable;
    • be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;
    • be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise;
    • be given an opportunity to ask questions concerning the experiment or the procedures involved;
    • be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice;
    • be given a copy of the signed and dated consent form; and
    • be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.