Evaluation of the Outcome of Fecal Microbiota Transplantation

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy, Fecal Microbiota Transplantation, TIPS

In brief

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.

Key facts

Study ID

NCT07454408

Run by

Air Force Military Medical University, China

People needed

40

Starts

2026-03-07

Expected to finish

2028-06-30

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged between 18 and 75 years old
• Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery
• Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention)
• Provided written informed consent from the patient

You may not qualify if…

• Malignant tumors of the liver, gastrointestinal tract or other systems
• Uncontrolled severe active infection (>grade 2) or sepsis
• Spontaneous bacterial peritonitis
• Complicated with severe cardiac, renal or pulmonary insufficiency
• Other neuropsychiatric diseases, including dementia
• Budd-Chiari syndrome
• Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)
• History of gastrointestinal surgery (e.g., colectomy) within 3 months before enrollment
• Pregnant or lactating subjects
• Poor compliance judged by the investigator
• Model for End-Stage Liver Disease (MELD) score >17
• Tumor, immunodeficiency, or receiving immunosuppressive therapy within 3 months before enrollment
• Patients who have used other prebiotics, probiotics or fecal microbiota transplantation (FMT) before enrollment

Where it is running

• Xi'an International Medical Center Hospital — Xi’an, Shanxi, China

Full record on ClinicalTrials.gov

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