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FMT in Cirrhosis and Hepatic Encephalopathy

NCT03796598 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-25

Study results available
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Summary

Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of care treatments. Repeated episodes of confusion can make it difficult for patients to function and may result in multiple admissions to the hospital and burden on the family. The investigators have studied using a healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in small studies with good results. In this trial the investigators propose to perform these procedures using an upper and lower route in Veterans who suffer from this condition and follow them for safety and HE and related hospitalizations over 6 months. The investigators will compare this to placebo treatments and hope that this intervention can improve the health and daily functioning of affected patients.

Conditions

  • Cirrhosis
  • Hepatic Encephalopathy

Interventions

DRUG

Fecal Microbial transplant Capsules

Oral capsules of FMT

DRUG

Fecal Microbial Transplant Enema

FMT enema

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jasmohan S. Bajaj, MD MS · Hunter Holmes McGuire VA Medical Center, Richmond, VA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2023-12-19
Completion
2023-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03796598 on ClinicalTrials.gov