NCT03439982

Fecal Transplant for Hepatic Encephalopathy

A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Detailed description

Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
BIOLOGICAL	FMT	FMT processed from routinely screened donors

Timeline

• Start date: 2016-04-12
• Primary completion: 2019-08-07
• Completion: 2021-03-18
• First posted: 2018-02-20
• Last updated: 2022-06-10

Locations

1 site across 1 country: Canada