RECRUITING

Fecal Microbiota Transplant for Autobrewery Syndrome

Talk to us

Conditions

Auto-Brewery SyndromeGut Fermentation Syndromefecal microbiota transplant

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Fecal Microbiota Transplant for Autobrewery Syndrome

Quick Facts

Study Start:2025-01-24
Study Completion:2030-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06083142

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Active ABS including at least 3 flares by either serum or breath alcohol levels in the past year (blood or breath samples)
  3. * Subject's microbiome produces alcohol ex vivo in bioreactor (Schnabl laboratory)
  4. * Willing and able to travel to Boston for in person assessment (modest reimbursement available)
  5. * Willing to stop antifungals, and any other complimentary therapies for ABS, if taking
  6. * 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.
  7. * Local physician contact available
  1. * Unwilling/unable to swallow large capsules (e.g.esophageal stricture or hiatal hernia)
  2. * Delayed gastric emptying syndrome
  3. * Known chronic aspiration, or chronic nausea/vomiting
  4. * Pregnant (pregnancy testing will be performed in women of childbearing potential; women over 52 with no menses for 12 months will not require testing)
  5. * Patients with an acute active illness or acute exacerbation of underlying comorbid condition.
  6. * 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.
  7. * Patients with decompensated cirrhosis, advanced HIV/AIDS, recent bone marrow transplant, or other severe immunodeficiency.
  8. * Severe food allergy or intolerance (donors are omnivores and do not maintain dietary restrictions)
  9. * Cannot document at least 2 COVID vaccinations. Those refusing all COVID vaccination are not eligible for FMT.
  10. * Ulcerative colitis or Crohn's disease (microbiome manipulation may precipitate a flare of these illnesses).
  11. * 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)
  12. * Taking warfarin (known to be affected by dietary and microbiome changes). NOACs do not exclude.
  13. * 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
  14. * Known biliary structural abnormalities.
  15. * Allergy to erythromycin, neomycin, or rifaximin.
  16. * Type I diabetes mellitus
  17. * History of pancreatitis or biliary sepsis

Contacts and Locations

Study Contact

Elizabeth Hohmann, MD
CONTACT
617-724-7532
ehohmann@partners.org

Principal Investigator

Elizabeth Hohmann, MD
PRINCIPAL_INVESTIGATOR
MGH

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Elizabeth Hohmann, MD, PRINCIPAL_INVESTIGATOR, MGH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24
Study Completion Date2030-08-31

Study Record Updates

Study Start Date2025-01-24
Study Completion Date2030-08-31

Terms related to this study

Keywords Provided by Researchers

  • fecal microbiota transplant

Additional Relevant MeSH Terms

  • Auto-Brewery Syndrome
  • Gut Fermentation Syndrome