Fecal Microbiota Transplant for Autobrewery Syndrome

Description

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

Conditions

Auto-Brewery Syndrome, Gut Fermentation Syndrome

Talk to us

Study Overview

On this page

Study Details

Study overview

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

Fecal Microbiota Transplant for Autobrewery Syndrome

Fecal Microbiota Transplant for Autobrewery Syndrome

Condition
Auto-Brewery Syndrome
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Elizabeth Hohmann, MD, PRINCIPAL_INVESTIGATOR, MGH

Study Record Dates

2030-08-31