Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT07528690
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cirrhosis
  • Hepatic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microbiota transplant therapy (MTT) capsules — BIOLOGICAL
    MTP-101-C is manufactured using cGMP protocols in the Molecular and Cellular Therapeutics (MCT) facility at the University of Minnesota.
  • Placebo capsule — OTHER
    Placebo capsule

Study Details

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.

Key Dates

Start date
Oct 30, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2030
Completion
Mar 3, 2031

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MTT
    Microbiota transplant therapy (MTT) capsules
  • Placebo Comparator: Placebo
    Placebo capsule

Primary Outcome Measure

Recurrence of Hepatic Encephalopathy (HE) [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
CERC (VISN1, West Haven, CT)West HavenConnecticut06516-2770
Lynn Buchwalder
[email protected]
203-932-5711
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Elizabeth Hernandez
[email protected]
469-231-9343
Richmond VA Medical Center, Richmond, VARichmondVirginia23249-0001
Haley Obolewicz
[email protected]
804-675-5705
Jasmohan S. Bajaj, MD MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Haven, CT

By research site
CERC (VISN1, West Haven, CT)· West Haven, CTVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX· Dallas, TXRichmond VA Medical Center, Richmond, VA· Richmond, VA

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