Fecal transplant plus standard therapy for refractory hepatic encephalopathy after TIPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-center, parallel-group exploratory trial enrolling 26 adults with recurrent overt hepatic encephalopathy after TIPS who continue rifaximin and lactulose. Participants receive fecal microbiota transplantation via nasojejunal tube at 100 mL twice daily for 3 days during episodes of encephalopathy, with possible adjunctive dietary prebiotic support to aid microbiota restoration. All participants stay on standard therapy, and the study explores safety and preliminary signs of efficacy of the microbiota intervention and the potential benefit of prebiotics. The trial aims to better understand whether reshaping the gut microbiota can reduce episodes and aid recovery in this difficult-to-treat population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18 - 75 years old, both genders are eligible
* Successful implementation of covered stent TIPS
* Those who experienced recurrence of hepatic encephalopathy after TIPS surgery and still used lactulose and rifaximin (within 6 months after intervention with rifaximin and lactulose, West Haven grade ≥ 2 hepatic encephalopathy occurred at least 2 times)
* Meet the conditions for receiving fecal microbiota transplantation through nasogastric tube (no severe anatomical abnormalities in the upper digestive tract; basic intestinal motility is normal; can tolerate the insertion of nasogastric tube and the subsequent infusion process)
* Obtain the patient's written informed consent

Exclusion Criteria:

* Patients with active gastrointestinal bleeding or perforation accompanied by severe damage to the intestinal barrier due to various reasons
* Patients with congenital or acquired immunodeficiency diseases, those who have received high-risk immunosuppressive or cytotoxic drug treatment within the recent 3 months, and those with severe immunosuppression (neutrophil count \< 1.5×10⁶ cells/L; CD4+ T cell count \< 2.0×10⁵ cells/L)
* Patients with malignant tumors of the liver or gastrointestinal tract, patients with spontaneous bacterial peritonitis, and patients with Budd-Chiari syndrome
* Patients with severe heart, kidney, or lung dysfunction (NYHA III-IV grade or unstable heart failure; eGFR \< 30 ml/min/1.73m² or requiring dialysis; respiratory failure or requiring long-term oxygen therapy)
* Unstable vital signs (body temperature, heart rate, blood pressure, breathing)
* History of gastrointestinal surgery within the past 3 months, such as colon resection
* Patients planning to undergo liver transplantation within 6 months
* Patients who have undergone FMT within the past 3 months
* Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)
* Other neurological and psychiatric disorders, including dementia, Parkinson's disease, and post-stroke sequelae
* Pregnant or lactating subjects
* Subjects considered to have poor compliance by the investigator

Where it's running

• Xi'an International Medical Center Hospital
  Xi'an, China Recruiting

Study contacts

• Principal investigator: Guohong HAN, Professor — Xi'an International Medical Center Hospital
• Study coordinator: Guohong HAN, Professor
• Email: 13991969930@126.com
• Phone: 13991969930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using TIPS before sleeve gastrectomy to improve outcomes for people with cirrhosis and severe obesity

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.