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

March 6, 2026 updated by: Cristian Ichim
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Sibiu, Romania, 550245
        • County Clinical Emergency Hospital of Sibiu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal microbiota transplantation (FMT) in patients with liver cirrhosis
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.
Biological: Fecal microbiota transplantation
Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.
Other Names:
  • Colonoscopy
No Intervention: Control
The control group will include patients who will be monitored for their progress while receiving standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At one month post-FMT.
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.
At one month post-FMT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristian Ichim

Investigators

  • Study Chair: Victoria Birlutiu, Prof. Dr., County Clinical Emergency Hospital of Sibiu
  • Study Director: Adrian Boicean, Prof. Dr., County Clinical Emergency Hospital of Sibiu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

June 23, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No: 3505/15.02.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study results will be made public and other researchers will be able to receive the anonymized database upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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