The smell caused by the condition can affect friendships, work, school, relationships, and mental health. Some people feel isolated or hopeless because there are very few treatments available.
Now, there may finally be some hopeful news.
This is important because it means the treatment has moved beyond laboratory testing and is now entering human clinical trials.
BM109 is a new kind of treatment called a live biotherapeutic product (LBP).
That means it uses living helpful bacteria to improve health.
The bacteria used in BM109 is a naturally discovered bacteria called:
Paracoccus aminovorans
BioMe says these bacteria can:
Break down TMA
Break down TMAO
Help remove odor-causing chemicals from the body
The goal is simple:
Reduce the chemicals that cause the smell before they build up.
This is different from many current treatments that only try to manage symptoms.
The FDA has now allowed BM109 to move into Phase 1/2a clinical trials.
That means researchers will now test:
Safety
Side effects
Whether it actually helps TMAU patients
The studies will involve real people with TMAU, not healthy volunteers.
The trials will be led by researchers connected to:
Yale University
Mayo Clinic
These are respected medical institutions in the United States.
It is important to stay realistic.
BM109 is NOT approved yet.
The treatment is still being tested.
That means:
Nobody knows yet how well it will work
Nobody knows if it will work for everyone
It could still fail during trials
But this is still a very meaningful step because TMAU has received very little research attention for many years.
For many patients, simply seeing a treatment move into human trials brings hope.
BioMe says TMAO may also be connected to:
Heart disease
Stroke
Kidney disease
Because of this, the company hopes BM109 may someday help with those conditions too.
But right now, the main focus is TMAU.
BioMe is also working on another bacteria-based product called BM107A.
This product is being studied for:
IBS (irritable bowel syndrome)
Colon health
Constipation
Inflammation
Brain and cognitive health
It works differently from BM109 and focuses on producing a healthy substance called butyrate in the gut.
People with TMAU often feel ignored by the medical system.
Many have spent years searching for answers, support, and understanding.
While BM109 is still experimental, this news shows that researchers are finally taking TMAU more seriously.
For now, the best thing patients can do is stay informed, stay connected with support communities, and watch for future updates from clinical trials.
Hope may still be early - but it is real.
REFERENCES
You JS, Yoon CE, Kim JB, Alrahman MA, Jung HY, Yoon MY, Kim YB, Lee SG, Nam HS, Yoon SS. Microbiome-Targeted Reduction of Circulating Trimethylamine N-Oxide Mitigates Ischemic Stroke Risk. bioRxiv. 2026:2026-04.
Kim SH, Yoon MY, Yoon SS. TMAO and the gut microbiome: implications for the CVD-CKD-IBD axis. Annals of medicine. 2025 Dec 31;57(1):2522324.
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