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Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)

NCT07528690 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-04-14

No results posted yet for this study

Summary

The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis

Interventions

BIOLOGICAL

Microbiota transplant therapy (MTT) capsules

MTP-101-C is manufactured using cGMP protocols in the Molecular and Cellular Therapeutics (MCT) facility at the University of Minnesota.

OTHER

Placebo capsule

Placebo capsule

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2030-10-31
Completion
2031-03-03
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 NCT07528690 on ClinicalTrials.gov