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Explore the Efficacy and Safety of FMT With Different Bacterial Doses in the Treatment of Hepatic Encephalopathy

NCT05669651 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-24

No results posted yet for this study

Summary

Hepatic encephalopathy (HE) is one of the most serious complications of end-stage liver disease and an independent predictor of death in patients with liver cirrhosis. Recurrent hepatic encephalopathy is defined as recurrent hepatic encephalopathy after rifaximin combined with lactulose treatment. This project designs a prospective, multicenter cohort study on the treatment of recurrent hepatic encephalopathy with fecal microbiota transplantation, carries out the comparison of fecal microbiota transplantation with different amounts of bacteria, and the dynamic sequencing of the macro genome of the recipient's stool, compares the effectiveness and safety of fecal microbiota transplantation with different amounts of bacteria in the treatment of recurrent hepatic encephalopathy, and explores the internal mechanism of different effects, providing a new idea for the treatment of recurrent HE in clinical practice.

Conditions

  • Hepatic Encephalopathy

Interventions

OTHER

Fecal Microbiota Transplantation

Fecal microbiota transplantation (FMT) refers to the transplantation of functional flora from healthy people's feces into patients' intestines to rebuild new intestinal flora and achieve the treatment of intestinal and parenteral diseases. In this study, 100 patients with recurrent hepatic encephalopathy were randomly divided into 1:1 groups to receive FMT with different amounts of bacteria, observe the therapeutic effect and adverse reactions of hepatic encephalopathy, and evaluate the effectiveness and safety of the two groups of patients. At the same time, the blood and stool samples of patients with recurrent hepatic encephalopathy before and after FMT were collected clinically, the composition of bile acid and other metabolites in stool and serum samples was analyzed, and the effective core flora was identified to clarify the mechanism of intestinal bacteria transplantation for the treatment of recurrent hepatic encephalopathy.

Sponsors & Collaborators

  • Hainv Gao

    lead OTHER

Principal Investigators

  • Hainv Gao, doctor · Shulan (Hangzhou) Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669651 on ClinicalTrials.gov