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

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

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Key information

Conditions

Liver Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

County Clinical Emergency Hospital of Sibiu

Sibiu, 550245, Romania

About this study

Participants in the experimental group will receive fecal microbiota transplantation (FMT) from a screened healthy donor. Each patient will undergo colonoscopic delivery of a minimum of 70 grams of donor fecal material into the cecum. The study will assess outcomes by monitoring clinical status, laboratory tests, imaging results and stool analyses (including assessment of micro-RNA profiles), comparing changes from baseline and with the control group. Participants will undergo scheduled re-evaluations at approximately 1 month post-transplant (timing may vary slightly due to clinical or logistical considerations).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fecal microbiota transplantation

Biological

Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.

Other names: Colonoscopy

Primary outcomes

Liver Stiffness by Transient Elastography (FibroScan)

Time frame: At one month post-FMT.

Liver fibrosis was assessed using transient elastography (FibroScan) one month after fecal microbiota transplantation (FMT). Liver stiffness values, expressed in kilopascals (kPa), were used to quantify fibrosis. Multiple measurements were taken per participant, and the median value was reported. Lower kPa values indicate less fibrosis (better outcome), while higher values indicate more severe fibrosis (worse outcome).
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy

Time frame: At one month post-FMT.

Hepatic encephalopathy (HE) was monitored in all participants at one month after fecal microbiota transplantation (FMT) using the West Haven criteria (Grade 0-IV). Higher grades indicate more severe encephalopathy.

Sponsors and collaborators

Lead sponsor

Cristian Ichim

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jun 27, 2024
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed