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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Microbiota transplant therapy (MTT) capsules
Biological/VaccineMTP-101-C is manufactured using cGMP protocols in the Molecular and Cellular Therapeutics (MCT) facility at the University of Minnesota.
Placebo capsule
Other interventionPlacebo capsule
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: MTTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of Hepatic Encephalopathy (HE)
HE episodes that requires hospitalization, ER visits, or medication changes prompted under medical supervision.
Time frame
6 monthsSecondary outcomes
1
Non-elective Hospitalizations
Cirrhosis-related, relatedness to MTT or all-cause
Time frame
6 months2
Death
Death
Time frame
6 months3
Liver transplant
Liver transplant
Time frame
6 months4
Health-related quality of life (HRQOL) assessment: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
PROMIS-29 used 29 items that are scored using T-scores (mean = 50, SD = 10) Maximum 100, minimum 0. Changes in t-scores between and within groups will be studied. High score=better
Time frame
6 monthsOther outcomes
1
Safety laboratories: Model for End-stage Liver Disease 3.0 (MELD3.0 score)
MELD3.0 score is a validated blood laboratory score of INR, bilirubin, creatinine, albumin and gender. High score=worse prognosis
Time frame
6 months2
Serum ammonia
Serum ammonia levels will be drawn and analyzed using local clinical laboratories.
Time frame
6 months3
Pathophysiological: Microbiota changes
Stool microbiota composition and functional change including serum metabolomics
Time frame
6 months4
Pathophysiological: Inflammation
Serum inflammatory cytokines
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: