Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
21 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
Disqualifiers
MELD3.0 score>22
WBC count<1000
non-elective hospitalization or overt HE episode within 1 month
on dialysis
Trial design
Treatments tested in this trial
- Microbiota transplant therapy (MTT) capsules
- Placebo capsule
Treatment groups
162 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov