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Oral Fecal Transplant in Cirrhosis

NCT03152188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-19

No results posted yet for this study

Summary

To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis and hepatic encephalopathy

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis, Liver

Interventions

DRUG

FMT

Fifteen FMT Openbiome capsules administered at the same time

OTHER

Placebo

Fifteen placebo capsules administered at the same time

Sponsors & Collaborators

  • OpenBiome

    collaborator INDUSTRY

  • Medical College of Wisconsin

    collaborator OTHER

  • Hunter Holmes McGuire VA Medical Center

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Jasmohan Bajaj, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2018-11-12
Completion
2018-11-12
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 NCT03152188 on ClinicalTrials.gov