search
Back to results

Fecal Microbiota Transplant for Autobrewery Syndrome

Primary Purpose

Auto-Brewery Syndrome, Gut Fermentation Syndrome

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal microbiota transplantation capsules
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auto-Brewery Syndrome focused on measuring fecal microbiota transplant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. Type I diabetes mellitus History of pancreatitis or biliary sepsis

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active FMT

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Blood Alcohol Level
Plasma blood alcohol level
Stool bioreactor ethanol production
Presence or absence of elevated alcohol level when stool is cultured in a bioreactor
weight
Subject weight in kg
Microbiome analysis of stool samples
Comparison of stool microbiome to subject's baseline and donor

Full Information

First Posted
May 2, 2023
Last Updated
October 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT06083142
Brief Title
Fecal Microbiota Transplant for Autobrewery Syndrome
Official Title
Fecal Microbiota Transplant for Autobrewery Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
August 31, 2029 (Anticipated)
Study Completion Date
August 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auto-Brewery Syndrome, Gut Fermentation Syndrome
Keywords
fecal microbiota transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active FMT
Arm Type
Experimental
Arm Description
Active FMT (5 doses) over 7 days. Each dose contains 15 capsules.
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation capsules
Intervention Description
Fecal microbiota transplantation capsules
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Safety outcomes of special interest include: Fever, diarrhea, nausea, vomiting, pain/bloating, bacteremia or transmission of GI infection
Time Frame
Over 6 months.
Title
Adequate dosing of FMT
Description
Adequate dosing is defined as subjects completed the gut cleanse and ingesting at least 3/5 planned doses of FMT capsules
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Blood Alcohol Level
Description
Plasma blood alcohol level
Time Frame
Over 6 months
Title
Stool bioreactor ethanol production
Description
Presence or absence of elevated alcohol level when stool is cultured in a bioreactor
Time Frame
Over 6 monthis
Title
weight
Description
Subject weight in kg
Time Frame
over 6 months
Title
Microbiome analysis of stool samples
Description
Comparison of stool microbiome to subject's baseline and donor
Time Frame
over 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Type I diabetes mellitus History of pancreatitis or biliary sepsis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hohmann, MD
Phone
617-724-7532
Email
ehohmann@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hohmann, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
conded data will be shared upon request
IPD Sharing Time Frame
At completion of study
IPD Sharing Access Criteria
upon request

Learn more about this trial

Fecal Microbiota Transplant for Autobrewery Syndrome

We'll reach out to this number within 24 hrs