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

NCT05669651 | Unknown

• 1 other identifier: Shulan (Hang zhou)2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hepatic encephalopathy; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of the first breakthrough episode of hepatic encephalopathy after FMT.

  West-Haven Grade ≥2 that occurs within 12 weeks is defined as the first breakthrough episode of hepatic encephalopathy after FMT. Breakthrough attack patients identified as FMT is invalid, no breakthrough attack patients identified as FMT is effective, at the same time compare the advantages and disadvantages of two ways of FMT efficacy.

  12 weeks

Secondary Outcomes (2)

• FMT related serious adverse events

  one month

• FMT related adverse events

  one month

Study Arms (2)

Low dose of group

EXPERIMENTAL

Complete the fecal bacteria transplantation through the upper digestive tract: 1. Intestinal preparation: Amoxicillin 0.5g bid, metronidazole 0.4g bid and levofloxacin 0.5g qd for 3 days. 2. FMT: After 12h of antibiotic discontinuation, the total amount of bacterial liquid was 400ml, 100ml each time, Q12h, 2 days after 12h of antibiotic discontinuation.

Other: Fecal Microbiota Transplantation

High dose of group

EXPERIMENTAL

Complete the fecal bacteria transplantation through the upper digestive tract: 1. Intestinal preparation: Amoxicillin 0.5g bid, metronidazole 0.4g bid and levofloxacin 0.5g qd for 3 days. 2. FMT: After 12h of antibiotic discontinuation, the total amount of bacterial liquid was 800ml, 100ml each time, Q12h, 4 days .

Other: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation OTHER

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.

High dose of group; Low dose of group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• At least two obvious episodes of hepatic encephalopathy (West-Haven ≥ 2 ) were related to cirrhosis in the first 6 months, and the condition was in remission (West Haven grade 0 or 1) at the time of enrollment. The attack of hepatic encephalopathy caused by gastrointestinal bleeding requiring at least 2 units of blood transfusion, the use of sedatives, renal failure requiring dialysis or central nervous system injury is not recorded as the previous attack;
• MELD score i ≤ 25 points (score range is 6-40, the higher the score is, the more serious the disease is)
• Meet the requirements for receiving FMT through nasojejunal tube
• The subject (or guardian) has signed the informed consent form

You may not qualify if:

• Patients expected to undergo liver transplantation within 1 month
• Patients with known causes of hepatic encephalopathy (including gastrointestinal bleeding and placement of portal systemic shunt or transjugular intrahepatic portal systemic shunt) within 3 months
• There are chronic renal insufficiency (creatinine level \> 2.0mg/dl), respiratory insufficiency, anemia (HB \< 8g / dl), electrolyte abnormalities (serum sodium \< 125umol / L; serum calcium \> 10mg / dl \[2.5umol / l\]; or serum potassium \< 2.5 mmol / L)
• Heavy drinking in recent 12 weeks
• Have used drugs that affect the psychometric score of hepatic encephalopathy (PHEs), such as antidepressants and sedative hypnosis, in recent 4 weeks
• Patients who are allergic to antibiotics before treatment
• Infection (pathogen obtained through sterile sites)
• Patients with chronic endogenous gastrointestinal diseases, such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis), irritable bowel syndrome
• Suffering from neurological diseases, such as stroke, epilepsy, dementia and Parkinson's disease
• Pregnant or lactating patients (urine pregnancy test will be used for examination)
• Patients who cannot provide informed consent
• Patients who are unwilling or unable to undergo indwelling nasojejunal tube
• Other researchers think it is not suitable to be included in this experiment

Sponsors & Collaborators

• Hainv Gao: lead

Study Sites (1)

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (14)

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MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Hainv Gao, doctor

  Shulan (Hangzhou) Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 3, 2023
• Study Start: December 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)