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Microbiota Therapy

Fecal Microbiota Transplant for Auto-Brewery Syndrome

Phase < 1
Waitlist Available
Led By Elizabeth Hohmann, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Known chronic aspiration, or chronic nausea/vomiting
Cannot document at least 2 COVID vaccinations. Those refusing all COVID vaccination are not eligible for FMT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if a gut cleanout and fecal transplant could be safe and successful for those with ABS.

Who is the study for?
This trial is for adults aged 18-70 with Auto-Brewery Syndrome (ABS) who've had symptoms for at least a year, including alcohol production in the gut. They must have experienced multiple ABS flares and be able to travel to Boston. Excluded are those unable to swallow large capsules, pregnant women, people with severe illnesses or immune deficiencies, certain medication users, and individuals not fully vaccinated against COVID.
What is being tested?
The study tests fecal microbiota transplantation (FMT) via oral capsules after a 'gut cleanout' process. Participants will take five doses over one week and then be monitored for six months. The research aims to determine if FMT is safe and can help manage ABS by altering gut bacteria.
What are the potential side effects?
Potential side effects of FMT may include digestive discomfort, bloating, nausea, changes in bowel habits or allergic reactions. Since participants will undergo antibiotic treatment and colon cleansing beforehand, they might also experience cramps or dehydration.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I often feel nauseous or vomit, or I frequently inhale food into my lungs.
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I have received at least 2 COVID vaccinations.
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I have known issues with my bile ducts.
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I have had pancreatitis or an infection in my bile ducts before.
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I cannot swallow large pills due to throat issues.
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I have delayed gastric emptying.
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I do not have a sudden illness or worsening of a long-term health problem.
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I have Type I diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adequate dosing of FMT
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary study objectives
Blood Alcohol Level
Microbiome analysis of stool samples
Stool bioreactor ethanol production
+1 more

Side effects data

From 2018 Phase 2 trial • 48 Patients • NCT02328547
10%
Abdominal Pain
8%
Nausea
6%
Worsening of Diarrhea
4%
Constipation
4%
Bloating
4%
Regurgitation/Emesis
4%
Fatigue
2%
Gas
2%
Belching
2%
Loss of Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
FMT Capsules
Placebo Capsules

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active FMTExperimental Treatment1 Intervention
Active FMT (5 doses) over 7 days. Each dose contains 15 capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal microbiota transplantation capsules
2015
Completed Phase 2
~50

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,323 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,603 Total Patients Enrolled
University of California, San DiegoOTHER
1,180 Previous Clinical Trials
1,575,038 Total Patients Enrolled
~5 spots leftby Aug 2029
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