Fecal Microbiota Transplant for Auto-Brewery Syndrome

Overseen By Elizabeth Hohmann, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must not be taking: Antifungals, Warfarin, Immunosuppressants

Disqualifiers: Pregnancy, Severe immunodeficiency, Ulcerative colitis, Crohn's disease, Type I diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1 week

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fecal microbiota transplantation (FMT) using capsules is safe and feasible for individuals with auto-brewery syndrome (ABS), a condition where the gut produces alcohol, causing symptoms similar to intoxication. Participants will undergo a gut cleanout and take five doses of FMT capsules over a week, followed by six months of observation. The trial suits those who have experienced ABS symptoms for at least a year, with at least three flare-ups, and can travel to Boston for assessments. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

Participants must stop taking antifungals and any other complementary therapies for auto-brewery syndrome if they are currently using them. The protocol does not specify other medications, but certain medications like warfarin and suppressive antibacterial agents may affect eligibility.

What prior data suggests that fecal microbiota transplantation is safe for auto-brewery syndrome?

Research has shown that fecal microbiota transplantation (FMT) is generally safe and well-tolerated. Studies have found that most short-term risks are mild and related to the method of administration, such as stomach upset or bloating. These mild effects are common with many treatments and usually resolve on their own.

For long-term safety, FMT remains under study. However, it has been used safely in other conditions, even in individuals with higher health risks. This suggests that FMT could be safe for those with auto-brewery syndrome as well.

Overall, evidence from previous research supports that FMT is both safe and manageable for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fecal Microbiota Transplantation (FMT) is unique because it directly targets the root cause of Auto-Brewery Syndrome by restoring a healthy balance of gut bacteria. Unlike most treatments that focus on managing symptoms with medications or dietary adjustments, FMT introduces beneficial bacteria to outcompete the yeast responsible for producing alcohol in the gut. Researchers are excited about this approach because it offers a potential long-term solution by addressing the underlying microbiome imbalance, rather than just alleviating symptoms. Plus, FMT is administered in capsule form, making it a non-invasive and straightforward option compared to more traditional methods.

What evidence suggests that fecal microbiota transplantation might be an effective treatment for auto-brewery syndrome?

Research has shown that fecal microbiota transplantation (FMT) effectively treats recurring Clostridium difficile infections caused by harmful gut bacteria. This treatment transfers healthy bacteria from a donor's stool to restore balance in the recipient's gut. Early findings suggest FMT might also help with other gut-related conditions, though limited information exists on its effects on auto-brewery syndrome (ABS). ABS is a condition where the gut converts carbohydrates into alcohol. One case study showed that FMT might help manage ABS symptoms. In this trial, participants will receive active FMT to explore its potential benefits for ABS. Although data on FMT for ABS remains limited, restoring healthy gut bacteria suggests potential benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Hohmann, MD

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with Auto-Brewery Syndrome (ABS) who've had symptoms for at least a year, including alcohol production in the gut. They must have experienced multiple ABS flares and be able to travel to Boston. Excluded are those unable to swallow large capsules, pregnant women, people with severe illnesses or immune deficiencies, certain medication users, and individuals not fully vaccinated against COVID.

Inclusion Criteria

Active ABS including at least 3 flares by either serum or breath alcohol levels in the past year (blood or breath samples)

My microbiome can produce alcohol outside my body.

I can travel to Boston for assessments and understand there's some reimbursement.

Exclusion Criteria

Severe food allergy or intolerance (donors are omnivores and do not maintain dietary restrictions)

Allergy to erythromycin, neomycin, or rifaximin

I often feel nauseous or vomit, or I frequently inhale food into my lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gut Cleanout

Participants undergo a gut cleanout with oral antibiotics and a colon cleanse

1 week

1 visit (in-person)

Treatment

Participants receive five oral doses of fecal transplant capsules over a week

1 week

Daily monitoring for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Intermittent visits at 2 weeks, 2 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplantation

Trial Overview The study tests fecal microbiota transplantation (FMT) via oral capsules after a 'gut cleanout' process. Participants will take five doses over one week and then be monitored for six months. The research aims to determine if FMT is safe and can help manage ABS by altering gut bacteria.

How Is the Trial Designed?

Group I: Active FMT Experimental Treatment 1 Intervention

Active FMT (5 doses) over 7 days. Each dose contains 15 capsules.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is a safe and effective treatment for Clostridioides difficile infection, and emerging evidence suggests it may also benefit various other conditions like irritable bowel syndrome and inflammatory bowel disease.

The review highlights the expanding applications of FMT beyond gastrointestinal issues, including its potential roles in treating liver disorders, metabolic disorders, and even neurological conditions, while also discussing regulatory aspects and future directions for FMT research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in gastrointestinal and extraintestinal disorders. Ianiro, G., Segal, JP., Mullish, BH., et al.[2021]

Fecal microbiota transplantation (FMT) showed significant long-term efficacy in reducing IBS symptoms, with response rates of 69.1% and 77.8% for the 30g and 60g treatment groups, respectively, at 2 years, and 64.9% and 71.8% at 3 years, compared to only 26.3% in the placebo group.

No long-term adverse events were reported, indicating that FMT is a safe intervention for IBS, with improvements in quality of life and a decrease in dysbiosis index observed in the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. El-Salhy, M., Winkel, R., Casen, C., et al.[2022]

In 2018, OpenBiome, a large stool bank, processed 4,271 fecal microbiota transplants (FMT) from 7,536 donations, indicating a robust system for providing FMT material to treat recurrent Clostridioides difficile infections.

The median time from donation to shipment of FMT preparations was 8.9 months, highlighting the need for improved efficiency in the stool banking process to enhance patient access to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. Chen, J., Zaman, A., Ramakrishna, B., et al.[2021]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.

However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. Rode, AA., Chehri, M., Petersen, AM., et al.[2019]

Fecal microbiota transplantation (FMT) is effective in treating recurrent Clostridium difficile infections, as demonstrated in a case study of a woman who was successfully treated with this method.

The case raises concerns about potential side effects, such as new-onset obesity, when using stool from overweight donors, suggesting the need for further research on the impact of donor characteristics on FMT outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight gain after fecal microbiota transplantation. Alang, N., Kelly, CR.[2022]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridium difficile infections, and research is expanding to explore its potential for treating other conditions related to chronic inflammation and autoimmunity.

Current studies on FMT for conditions like ulcerative colitis and metabolic syndrome show promise, but many lack rigorous methodology, highlighting the need for more standardized and well-designed trials to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation : current status and prospects]. Gilbert, B., Schrenzel, J.[2019]

Fecal microbiota transplantation (FMT) was performed on 26 patients with recurrent Clostridium difficile infection, showing a 92% success rate in preventing further diarrhea or CDI relapse over a follow-up period of up to 30 months.

The procedure was found to be simple and safe, with most patients remaining free of significant diarrhea after the treatment, highlighting FMT as a promising alternative to prolonged antibiotic courses for managing recurrent CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. Kelly, CR., de Leon, L., Jasutkar, N.[2022]

Capsulized autologous faecal microbiota transplantation (FMT) was found to be safe and well tolerated in a study of 24 healthy volunteers, with no serious side effects reported during the treatment.

While both the FMT and placebo groups showed improvements in general and intestinal health after antibiotic treatment, there was no significant difference in the time it took for participants to normalize their intestinal habits, indicating that FMT did not provide additional benefits over placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. Stefansson, M., Bladh, O., Flink, O., et al.[2023]

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

Autologous fecal microbiota transplantation (a-FMT) uses a person's own feces collected during a healthy state to restore gut microbiota, potentially offering a safer alternative to heterologous fecal microbiota transplantation (h-FMT), which carries risks of infectious exposure from donor stool.

While h-FMT has shown high cure rates (up to 90%) for recurrent Clostridioides difficile infection, its effectiveness for inflammatory bowel disease (IBD) is variable, with response rates between 24% and 50%, highlighting the complexity of IBD as a microbiome-driven disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fecal microbiota transplantation for the treatment of inflammatory bowel disease. Basson, AR., Zhou, Y., Seo, B., et al.[2021]

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

In a survey of 262 ulcerative colitis patients, 56.1% expressed willingness to undergo fecal microbiota transplantation (FMT) as a treatment option, motivated primarily by the effectiveness of the procedure and the failure of other therapies.

Concerns about FMT included the potential transmission of infectious agents and contamination of the stool graft, highlighting the need for safe implementation practices in this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient perception and approval of fecal microbiota transplantation (FMT) as an alternative treatment option for ulcerative colitis]. Roggenbrod, S., Schuler, C., Haller, B., et al.[2022]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06083142

Fecal Microbiota Transplant for Autobrewery Syndrome The goal of this clinical trial is to study fecal microbiota transplantation(FMT) by oral capsule in people already diagnosed with auto-brewery syndrome (ABS, ...

2. withpower.com withpower.com/trial/early-phase-1-syndrome-1-2024-cf38c

Fecal Microbiota Transplant for Auto-Brewery Syndrome Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026161/

Fecal microbiota transplantation: Uses, questions, and ethics Fecal microbiota transplantation (FMT) has rapidly grown in notoriety and popularity worldwide as a treatment for both recurrent and refractory C. difficile ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39647535/

Fecal microbiota transplantation in a long-standing auto- ... Fecal microbiota transplantation in a long-standing auto-brewery syndrome with complex symptomatology. J Hepatol. 2025 Apr;82(4):e186-e188.

5. mdpi.com mdpi.com/2227-9059/10/11/2742

Current Trends and Challenges of Fecal Microbiota ... ... microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. ... faecal microbiota transplant (FMT). Diabetes Obes. Metab ...

6. reporter.nih.gov reporter.nih.gov/search/13EBCA09468FC1D27598B8961CAA4A01A2FFCEB861BF/project-details/11197592

Fecal microbiota transplantation for auto-brewery syndrome Primary clinical outcomes are safety and feasibility; secondary and exploratory endpoints include clinical outcomes and assessment of flares by blood and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590097820300240

Fecal microbiota transplantation: Uses, questions, and ethics ... FMT research and assessing longitudinally for longterm safety outcomes of this procedure. With more and better evidence, clinicians will be better able to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9562921/

Safety and efficacy of fecal microbiota transplantation for ... Based on current evidence, the application of FMT in the treatment of autoimmune diseases is effective and relatively safe.