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Evaluation of the Outcome of Fecal Microbiota Transplantation
Sponsor: Air Force Military Medical University, China
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.
Official title: A Clinical Randomized Controlled Study on the Prevention and Treatment of Drug-refractory Hepatic Encephalopathy After TIPS With Fecal Microbiota Transplantation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-07
Completion Date
2028-06-30
Last Updated
2026-03-06
Healthy Volunteers
Yes
Interventions
Fecal Microbiota Transplantation
Fecal microbiota transplantation is used to reconstruct gut microbiota structure, regulate intestinal microecological homeostasis, improve intestinal barrier function, reduce systemic endotoxin load and inflammatory level, for the prevention and treatment of refractory hepatic encephalopathy after TIPS. The preparation is made from stool of qualified screened donors, processed under sterile conditions.
FMT Matched Placebo
Placebo preparation is identical to fecal microbiota transplantation preparation in appearance, dosage form, administration route and frequency, with no active biological or therapeutic components, used for the control arm of this randomized controlled trial.
Rifaximin、Lactulose
Rifaximin is a non-absorbable oral rifamycin antibiotic, used as standard medical therapy for hepatic encephalopathy, to reduce intestinal urease-producing bacteria and intestinal ammonia production.Lactulose is a synthetic disaccharide laxative, used as first-line standard medical therapy for hepatic encephalopathy, to acidify the intestinal lumen, reduce ammonia production and promote ammonia excretion.
Locations (1)
Xi'an International Medical Center Hospital
Xi’an, Shanxi, China