Status:
RECRUITING
Fecal Microbiota Transplant for Autobrewery Syndrome
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Auto-Brewery Syndrome
Gut Fermentation Syndrome
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
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, also known as gut fermentation syndrome)....
Detailed Description
The study is a single arm, open label pilot safety and feasibility study. Subjects will provide medical information related to their diagnosis of ABS. All subjects will have a baseline assessment (med...
Eligibility Criteria
Inclusion
- 18-70 with documented ABS symptoms for at least one year, including supervised ethanol testing or a positive glucose challenge test in a supervised setting.
- Active ABS including at least 3 flares by either serum or breath alcohol levels in the past year (blood or breath samples)
- Subject's microbiome produces alcohol ex vivo in bioreactor (Schnabl laboratory)
- Willing and able to travel to Boston for in person assessment (modest reimbursement available)
- Willing to stop antifungals, and any other complimentary therapies for ABS, if taking
- Medically able to withstand clean out. If participants are over 60, the subject must have previously tolerated a prior colonoscopic "prep" as part of prior routine care.
- Local physician contact available
Exclusion
- Unwilling/unable to swallow large capsules (e.g.esophageal stricture or hiatal hernia)
- Delayed gastric emptying syndrome
- Known chronic aspiration, or chronic nausea/vomiting
- Pregnant (pregnancy testing will be performed in women of childbearing potential; women over 52 with no menses for 12 months will not require testing)
- Patients with an acute active illness or acute exacerbation of underlying comorbid condition.
- Patients on unstable, or increasing immunosuppressive agents including high dose corticosteroids(40 mg prednisone daily or more), calcineurin inhibitors, escalating immunosuppression for organ rejection, active chemotherapy with expected neutropenia, current or neutropenia (ANC \<1000) within the last year.
- Patients with decompensated cirrhosis, advanced HIV/AIDS, recent bone marrow transplant, or other severe immunodeficiency.
- Severe food allergy or intolerance (donors are omnivores and do not maintain dietary restrictions)
- Cannot document at least 2 COVID vaccinations. Those refusing all COVID vaccination are not eligible for FMT.
- Ulcerative colitis or Crohn's disease (microbiome manipulation may precipitate a flare of these illnesses).
- Active HIV, hepatitis B or C infection (subjects with prior treated hepatitis C must have undetectable viral load; HIV positive subjects must be receiving anti-retroviral therapy with undetectable viral loads x 1 year minimum, Hepatitis B core antibody positive subjects are allowed if negative HepB surface antigen and antibody)
- Taking warfarin (known to be affected by dietary and microbiome changes). NOACs do not exclude.
- On suppressive antibacterial agents, or expected to receive prophylactic antibacterials within the year, for example a patient with a prosthetic heart valve who routinely receives dental prophylaxis, or patient with chronic UTIs anticipated to need treatment frequently
- Known biliary structural abnormalities.
- Allergy to erythromycin, neomycin, or rifaximin.
- Type I diabetes mellitus
- History of pancreatitis or biliary sepsis
Key Trial Info
Start Date :
February 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06083142
Start Date
February 14 2025
End Date
August 31 2030
Last Update
July 8 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114