Fecal Microbiota Transplant for Autobrewery Syndrome

NCT06083142 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2023p000579
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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). The main question it aims to answer: Is FMT safe and feasible in this syndrome? Participants will

1. 1.have a "gut cleanout" with oral antibiotics and a colon cleanse, similar to that administered before colonoscopy
2. 2.receive five oral doses of fecal transplant capsules over a week
3. 3.be followed for six months for safety and research samples

Conditions

Auto-Brewery Syndrome; Gut Fermentation Syndrome

Keywords

fecal microbiota transplant

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Safety outcomes of special interest include: Fever, diarrhea, nausea, vomiting, pain/bloating, bacteremia or transmission of GI infection

  Over 6 months.

• Adequate dosing of FMT

  Adequate dosing is defined as subjects completed the gut cleanse and ingesting at least 3/5 planned doses of FMT capsules

  7 days

Secondary Outcomes (4)

• Blood Alcohol Level

  Over 6 months

• Stool bioreactor ethanol production

  Over 6 monthis

• weight

  over 6 months

• Microbiome analysis of stool samples

  over 6 months.

Study Arms (1)

Active FMT

EXPERIMENTAL

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

Biological: Fecal microbiota transplantation capsules

Interventions

Fecal microbiota transplantation capsules BIOLOGICAL

Fecal microbiota transplantation capsules

Active FMT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Elizabeth Hohmann, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: October 13, 2023
• Study Start: February 14, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: At completion of study
• Access Criteria: upon request

Locations

US (1)