NCT06083142

Fecal Microbiota Transplant for Autobrewery Syndrome

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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

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 (medical history, exam, blood and stool samples ) at Massachusetts General Hospital in Boston. Those enrolled will receive a gut clean out procedure and 5 doses of FMT capsules in the 7 days after the clean out. Each individual ABS patient will receive capsules generated from a single donor, to minimize the risk of transmission of infectious agents. All subjects receive active treatment; there is no placebo. The primary objective of this study is to evaluate the safety and feasibility of the proposed procedures (antibiotic pretreatment, "clean out" and microbial restoration via capsule FMT), thus the primary endpoints will be collection of data regarding any FMT-related adverse events. Feasibility will be defined as taking 3 doses of FMT capsules which we believe can fully reconstitute a healthy microbiome based upon our and others work. Safety will be assessed daily for 7 days after FMT, and the intermitently over the 6 months after FMT, using standardized patient report scales and interviews as well as by clinical laboratories (at baseline and 2 weeks 2 months, and 6 months). Feasibility is defined as all subjects completing at least 3/5 planned doses of FMT capsules.

Conditions

• Auto-Brewery Syndrome
• Gut Fermentation Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbiota transplantation capsules	Fecal microbiota transplantation capsules

Timeline

• Start date: 2025-02-14
• Primary completion: 2029-08-31
• Completion: 2030-08-31
• First posted: 2023-10-13
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study