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Microbiota Therapy

Fecal Microbiota Transplant for Auto-Brewery Syndrome

Q: What are the qualifications for enrollment in this trial?

To be eligible for this trial, prospective participants must possess auto-brewery syndrome and fall between the age brackets of 18 to 70. Currently, 8 patients are being sought after in total.

Q: Are minors able to partake in this research study?

The cutoff age for enrolment in this trial is 70 years old. Patients younger than 18 are restricted to 373 clinical trials, while those over 65 have access to 1040 different studies.

Q: Is this research endeavor currently open to new participants?

Clinicaltrials.gov reports that this clinical trial is not currently enrolling patients, despite being initially listed on February 1st 2024 and last modified on October 12th 2023. However, 1477 other medical studies are recruiting right now.

Q: What hopes are researchers aiming to achieve with this empirical endeavor?

This 6 month clinical trial aims to determine the efficacy of FMT dosing. Secondary objectives include evaluating stool bioreactor ethanol production, weight changes in subjects, and comparing <a href="https://www.withpower.com/clinical-trials/microbiome">microbiome</a> analysis between baseline samples and donor stools.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adequate dosing of FMT

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Secondary outcome measures

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

Nausea

Worsening of Diarrhea

Fatigue

Constipation

Bloating

Regurgitation/Emesis

Gas

Belching

Loss of Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Capsules

FMT Capsules

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

Do I qualify?Apply below to find out

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

2,936 Previous Clinical Trials

13,198,715 Total Patients Enrolled

University of California, San DiegoOTHER

1,123 Previous Clinical Trials

1,552,831 Total Patients Enrolled

Elizabeth Hohmann, MDPrincipal InvestigatorMGH

3 Previous Clinical Trials

37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications for enrollment in this trial?

"To be eligible for this trial, prospective participants must possess auto-brewery syndrome and fall between the age brackets of 18 to 70. Currently, 8 patients are being sought after in total."

Answered by AI

Are minors able to partake in this research study?

"The cutoff age for enrolment in this trial is 70 years old. Patients younger than 18 are restricted to 373 clinical trials, while those over 65 have access to 1040 different studies."

Answered by AI

Is this research endeavor currently open to new participants?

"Clinicaltrials.gov reports that this clinical trial is not currently enrolling patients, despite being initially listed on February 1st 2024 and last modified on October 12th 2023. However, 1477 other medical studies are recruiting right now."

Answered by AI

What hopes are researchers aiming to achieve with this empirical endeavor?

"This 6 month clinical trial aims to determine the efficacy of FMT dosing. Secondary objectives include evaluating stool bioreactor ethanol production, weight changes in subjects, and comparing microbiome analysis between baseline samples and donor stools."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbiota Transplant for Autobrewery Syndrome

Elizabeth L. Hohmann, MD 2024. "Fecal Microbiota Transplant for Autobrewery Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083142.

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