At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial of VE303 to Treat Hepatic Encephalopathy
In Brief
A Phase 2 clinical trial evaluating Placebo, VE303, and 1 other intervention for Cirrhosis and Hepatic Encephalopathy. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy. Eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study. The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.
Study Details
Timeline
Interventions
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.
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.
All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).