Evaluation of the Outcome of Fecal Microbiota Transplantation

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.

Conditions

• Hepatic Encephalopathy
• Fecal Microbiota Transplantation
• TIPS

Interventions

BIOLOGICAL

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.

OTHER

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.

DRUG

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.

Sponsors & Collaborators

• Air Force Military Medical University, China

  lead OTHER

Principal Investigators

• Guohong HAN, Professor · Xi'an International Medical Center Hospital

• Guohong HAN, Professor · Xi'an International Medical Center Hospital

• Mingtao ZHAO · Xi'an Jiaotong University

• Menghao LI · Xi'an International Medical Center Hospital

• Heng ZENG · Xi'an International Medical Center Hospital

• Xing WANG · Xi'an International Medical Center Hospital

• Gui ZHANG · Xi'an International Medical Center Hospital

• Zhanxin YIN · Xi'an International Medical Center Hospital

• Ruijun LI · Xi'an International Medical Center Hospital

• Wei BAI · Xi'an International Medical Center Hospital

• Dongdong XIA · Xi'an International Medical Center Hospital

• Na ZHANG · Xi'an International Medical Center Hospital

• Zhengyu WANG · Xi'an International Medical Center Hospital

• Bohan LUO · Xi'an International Medical Center Hospital

• Feifei WU · Xi'an International Medical Center Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-07

Primary Completion

2028-06-06

Completion

2028-06-30

Countries

• China

Study Locations