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NCT06083142 · ClinicalTrials.gov registry record · Early Phase 1
Fecal Microbiota Transplant for Autobrewery Syndrome
A Early Phase 1 study of Auto-Brewery Syndrome and Gut Fermentation Syndrome, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06083142: Recruiting Early Phase 1 study of Auto-Brewery Syndrome and Gut Fermentation Syndrome, sponsored by Massachusetts General Hospital.
NCT06083142 is a Early Phase 1 study of Auto-Brewery Syndrome and Gut Fermentation Syndrome that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06083142, a Early Phase 1 study of Auto-Brewery Syndrome and Gut Fermentation Syndrome, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Safety outcomes of special interest include: Fever, diarrhea, nausea, vomiting, pain/bloating, bacteremia or transmission of GI infection
Conditions Studied
Interventions
- BIOLOGICAL Fecal microbiota transplantation capsules
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2030-08-31 |
| Phase | Early Phase 1 |
What NCT06083142 shows while recruiting
NCT06083142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Auto-Brewery Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Fecal microbiota transplantation capsules is the first listed.
NCT06083142 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06083142 about?
NCT06083142 is a clinical study titled "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, also known as gut fermentation syndrome). The main question it aims to answer: Is FMT safe and feasible in this syndrome? Participants will ...
What is the current status of trial NCT06083142?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2025-02-14. Estimated completion is 2030-08-31.
What conditions does trial NCT06083142 study?
This clinical trial studies the following conditions: Auto-Brewery Syndrome, Gut Fermentation Syndrome.
What interventions are being tested in trial NCT06083142?
The interventions under investigation include: Fecal microbiota transplantation capsules (BIOLOGICAL).
Who is sponsoring clinical trial NCT06083142?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06083142 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06083142's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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