Fecal Microbiota Transplant for Autobrewery Syndrome

Running, not enrolling · Early Phase 1

Conditions studied: Auto-Brewery Syndrome, Gut Fermentation Syndrome

In brief

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). The main question it aims to answer: Is FMT safe and feasible in this syndrome? Participants will 1. have a "gut cleanout" with oral antibiotics and a colon cleanse, similar to that administered before colonoscopy 2. receive five oral doses of fecal transplant capsules over a week 3. be followed for six months for safety and research samples

Key facts

Study ID: NCT06083142
Run by: Massachusetts General Hospital
People needed: 8
Starts: 2025-02-14
Expected to finish: 2030-08-31
Last updated by the study team: 2026-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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