Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis

Phase 3

Recruiting

• Conditions: Liver Cirrhosis
• Interventions: Biological: Fecal microbiota transplantation

• Registration Number: NCT06478602
• Lead Sponsor: Cristian Ichim

Brief Summary

The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of liver cirrhosis according to current protocols.
• Conscious and cooperative adult patients.

Exclusion Criteria

• Patients with hemodynamic and/or respiratory instability.
• Patients with contraindications for colonoscopy or fecal transplantation.
• Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
• Associated oncological pathology.
• Patients with other causes of severe immunodeficiencies.
• Lack of compliance with the conditions imposed by the research project.
• Patients who do not sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation (FMT) in patients with liver cirrhosis	Fecal microbiota transplantation	The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.

Primary Outcome Measures

Name	Time	Method
Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis.	Up to 3 months	The transfer of microbiota could potentially influence hepatic fibrosis via the gut-liver axis, as well as other complications caused by cirrhosis such as encephalopathy, ascites etc.
Implications of fecal microbiota transplantation in modulating the condition of other organs.	Up to 3 months	The transfer of microbiota could potentially modulate the function of other major organs in the body.

Trial Locations

Locations (1)

County Clinical Emergency Hospital of Sibiu; 🇷🇴 Sibiu, Romania