NCT02255617

Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (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 and Stroop as well as serum ammonia levels.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	Fecal transplant processed from routinely screened universal donors

Timeline

• Start date: 2014-07-23
• Primary completion: 2019-07-25
• Completion: 2019-09-23
• First posted: 2014-10-02
• Last updated: 2021-10-04

Locations

1 site across 1 country: Canada