VE303 for Treatment of Hepatic Encephalopathy (HE)

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

August 6, 2021

Primary Completion Date

April 10, 2023

Study Completion Date

August 30, 2023

Conditions
CirrhosisHepatic Encephalopathy
Interventions
DRUG

Placebo

Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.

DRUG

VE303

"Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.~The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules."

DRUG

oral vancomycin

All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).

Trial Locations (1)

48109

University of Michigan, Ann Arbor

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Vedanta Biosciences, Inc.

INDUSTRY

collaborator

American College of Gastroenterology

OTHER

collaborator

American Association for the Study of Liver Diseases

OTHER

lead

Patricia Bloom

OTHER

NCT04899115 - VE303 for Treatment of Hepatic Encephalopathy (HE) | Biotech Hunter | Biotech Hunter