Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)

NCT07528690 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GAST-006-25SIRBnet1909366
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

cirrhosis; hepatic encephalopathy; rifaximin; lactulose; microbiota transplant therapy

Outcome Measures

Primary Outcomes (1)

• Recurrence of Hepatic Encephalopathy (HE)

  HE episodes that requires hospitalization, ER visits, or medication changes prompted under medical supervision.

  6 months

Secondary Outcomes (7)

• Non-elective Hospitalizations

  6 months

• Death

  6 months

• Liver transplant

  6 months

• Health-related quality of life (HRQOL) assessment: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

  6 months

• Health-related quality of life (HRQOL) assessment: Sickness Impact Profile (SIP)

  6 months

Other Outcomes (4)

• Safety laboratories: Model for End-stage Liver Disease 3.0 (MELD3.0 score)

  6 months

• Serum ammonia

  6 months

• Pathophysiological: Microbiota changes

  6 months

Study Arms (2)

MTT

EXPERIMENTAL

Microbiota transplant therapy (MTT) capsules

Biological: Microbiota transplant therapy (MTT) capsules

Placebo

PLACEBO COMPARATOR

Placebo capsule

Other: Placebo capsule

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.

Also known as: MTP-101-C

MTT

Placebo capsule OTHER

Placebo capsule

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Cirrhosis diagnosed by any of the following in a patient with chronic liver disease
• Liver Biopsy
• Radiologic evidence of varices, cirrhosis or portal hypertension
• Laboratory evidence of platelet count \<110,000 or AST/ALT ratio\>1
• Endoscopic evidence of varices or portal hypertensive gastropathy
• Prior overt HE (patient can be on lactulose and/or rifaximin 4 weeks stable dosing)
• Able to give written, informed consent \[mini-mental status exam (MMSE)\]\>25 at the time of consenting)
• For lactulose only group: Prior HE not on rifaximin

You may not qualify if:

• Disease-related:
• MELD3.0 score\>22
• WBC count\<1000
• non-elective hospitalization or overt HE episode within 1 month
• on dialysis
• known untreated, luminal GI cancer
• chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease)
• Safety-related:
• Current dysphagia
• History of aspiration, intestinal obstruction or non-medication induced gastroparesis
• Ongoing absorbable antibiotic use
• History of anaphylactic food allergy
• Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
• Adverse event attributable to prior FMT (7) ASA Class V
• Pregnant or nursing patients

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

CERC (VISN1, West Haven, CT)

West Haven, Connecticut, 06516-2770, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

Location

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis

Interventions

monooxyethylene trimethylolpropane tristearate; Capsules

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jasmohan S. Bajaj, MD MS

  Richmond VA Medical Center, Richmond, VA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmohan S Bajaj, MD MS

CONTACT

(804) 675-5802; Jasmohan.Bajaj@va.gov

Brian C Davis, MD

CONTACT

(804) 675-5802; brian.davis5@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Half of the patients will be on lactulose alone and half also on rifaximin. This is an a priori division.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): March 3, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)