Clinical Trial

Evaluation of the Outcome of Fecal Microbiota Transplantation

Not Yet Recruiting Phase 1/2
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Summary
This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.
Trial Details
NCT Number NCT07454408
Lead Sponsor Air Force Military Medical University, China
Conditions Hepatic Encephalopathy, Fecal Microbiota Transplantation, TIPS
Enrollment 40 participants
Start Date 2026-03-07
Primary Completion 2028-06-06 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-06