Auto-Brewery SyndromeEarly Phase 1NCT06083142
Fecal Microbiota Transplant for Autobrewery Syndrome
A Early Phase 1 study testing Fecal microbiota transplantation capsules in people with Auto-Brewery Syndrome and Gut Fermentation Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Auto-Brewery Syndrome, Gut Fermentation Syndrome
- What is being tested?
- Fecal microbiota transplantation capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 31 Aug 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- have a "gut cleanout" with oral antibiotics and a colon cleanse, similar to that administered before colonoscopy
- receive five oral doses of fecal transplant capsules over a week
- be followed for six months for safety and research samples
Read the 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
- Being tested
- Fecal microbiota transplantation capsules
- Keywords
- fecal microbiota transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation capsulesBiological
Fecal microbiota transplantation capsules
| Study group | Role | What they receive |
|---|---|---|
| Active FMT | Experimental | Active FMT (5 doses) over 7 days. Each dose contains 15 capsules. Receives: Biological: Fecal microbiota transplantation capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days
Secondary outcomes (4)
Blood Alcohol Level
Plasma blood alcohol level
Measured: Over 6 months
Stool bioreactor ethanol production
Presence or absence of elevated alcohol level when stool is cultured in a bioreactor
Measured: Over 6 monthis
weight
Subject weight in kg
Measured: over 6 months
Microbiome analysis of stool samples
Comparison of stool microbiome to subject's baseline and donor
Measured: over 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start14 Feb 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto-Brewery SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Elizabeth L. Hohmann, MD, Massachusetts General Hospital
- Investigators
- Elizabeth Hohmann, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083142
- Sponsor's protocol ID
- 2023p000579
- Status last verified
- Apr 2026
- First submitted
- 2 May 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: coded data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant for Autobrewery Syndrome
- ClinicalTrials.gov ID
- NCT06083142
- Acronym / sponsor ID
- 2023p000579
- Conditions
- Auto-Brewery Syndrome, Gut Fermentation Syndrome
- Keywords
- fecal microbiota transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- have a "gut cleanout" with oral antibiotics and a colon cleanse, similar to that administered before colonoscopy
- receive five oral doses of fecal transplant capsules over a week
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active FMT | Experimental | Biological: Fecal microbiota transplantation capsulesActive FMT (5 doses) over 7 days. Each dose contains 15 capsules. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation capsulesFecal microbiota transplantation capsules | Biological | Active FMT |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Over 6 months.
Safety outcomes of special interest include: Fever, diarrhea, nausea, vomiting, pain/bloating, bacteremia or transmission of GI infection
Adequate dosing of FMT
Time frame: 7 days
Adequate dosing is defined as subjects completed the gut cleanse and ingesting at least 3/5 planned doses of FMT capsules
4 secondary outcomes
Blood Alcohol Level
Time frame: Over 6 months
Stool bioreactor ethanol production
Time frame: Over 6 monthis
weight
Time frame: over 6 months
Microbiome analysis of stool samples
Time frame: over 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. coded data will be shared upon request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Hohmann, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fecal microbiota transplantation capsules in people with Auto-Brewery Syndrome and Gut Fermentation Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: Over 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.