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Microbiota Transplant

Fecal Microbiota Transplant for Hepatic Encephalopathy

Phase 2
Waitlist Available
Led By Raymond T Chung, 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 before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)
Awards & highlights

Study Summary

This trial is testing whether transplanting bacteria from the colon of a healthy person into the colon of a patient with advanced liver disease, who is experiencing confusion due to a condition called hepatic encephalopathy, will help to improve the patient's neurological function.

Who is the study for?
This trial is for patients with advanced liver disease who've had at least one episode of hepatic encephalopathy (confusion due to liver problems) but are stable on current treatments. They must not have certain other health issues, recent drug or alcohol use, or be expecting a liver transplant soon.Check my eligibility
What is being tested?
The study tests if swallowing capsules containing healthy stool bacteria can improve brain function in liver disease patients compared to placebo capsules. It's a randomized controlled trial, meaning participants are randomly assigned to receive either the real treatment or a placebo.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or infection since fecal microbiota transplant involves introducing new bacteria into the body. However, specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)
This trial's timeline: 3 weeks for screening, Varies for treatment, and before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Psychometric Hepatic Encephalopathy Score (PHES)
Secondary outcome measures
36-Item Short Form Health Survey (SF-36)
Adverse events
Ammonia
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fecal Microbiota Transplant (FMT) oral capsulesExperimental Treatment1 Intervention
Subjects will receive 15 oral capsules of FMT on days 1, 2, 7, 14, and 21.
Group II: Placebo capsulesPlacebo Group1 Intervention
Subjects will receive placebo capsules on the same schedule as the experimental arm (days 1, 2, 7, 14, and 21).

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,959 Total Patients Enrolled
Center for Microbiome Informatics and TherapeuticsUNKNOWN
Raymond T Chung, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Encephalopathy Research Study Groups: Placebo capsules, Fecal Microbiota Transplant (FMT) oral capsules
~4 spots leftby May 2025
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