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

NCT06478602 | Completed Phase 3 Results DMC

• 1 other identifier: No: 3505/15.02.2023
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; Fecal microbiota transplantation; FMT; Chronic liver disease; Cirrhosis complications; micro-RNA; Fibrosis; Hepatic encephalopathy

Outcome Measures

Primary Outcomes (2)

• Liver Stiffness by Transient Elastography (FibroScan)

  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

  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.

Study Arms (2)

Fecal microbiota transplantation (FMT) in patients with liver cirrhosis

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will include patients who will be monitored for their progress while receiving standard treatment.

Interventions

Fecal microbiota transplantation BIOLOGICAL

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

Also known as: Colonoscopy

Fecal microbiota transplantation (FMT) in patients with liver cirrhosis

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristian Ichim: lead

Study Sites (1)

County Clinical Emergency Hospital of Sibiu

Sibiu, 550245, Romania

Location

Related Publications (4)

• Boicean A, Birlutiu V, Ichim C, Brusnic O, Onisor DM. Fecal Microbiota Transplantation in Liver Cirrhosis. Biomedicines. 2023 Oct 30;11(11):2930. doi: 10.3390/biomedicines11112930.

  PMID: 38001930 BACKGROUND

• Ichim C, Boicean A, Anderco P, Todor SB, Hasegan A, Birsan S, Birlutiu V. MicroRNAs in Liver Cirrhosis: Diagnostic and Therapeutic Perspectives-A Comprehensive Review. J Pers Med. 2025 Aug 14;15(8):376. doi: 10.3390/jpm15080376.

  PMID: 40863438 BACKGROUND

• Ichim C, Boicean A, Todor SB, Anderco P, Birlutiu V. Fecal Microbiota Transplantation in Patients with Alcohol-Associated Cirrhosis: A Clinical Trial. J Clin Med. 2025 Aug 24;14(17):5981. doi: 10.3390/jcm14175981.

  PMID: 40943741 RESULT

• Ichim C, Boicean A, Todor SB, Boeras I, Anderco P, Birlutiu V. Dynamics of Fecal microRNAs Following Fecal Microbiota Transplantation in Alcohol-Related Cirrhosis. J Clin Med. 2025 Dec 5;14(24):8623. doi: 10.3390/jcm14248623.

  PMID: 41464526 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Hepatic Encephalopathy

Interventions

Fecal Microbiota Transplantation; Colonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Ichim Cristian
• Organization: County Clinical Hospital Sibiu

cristian.ichim@ulbsibiu.ro

0040771643848

Study Officials

• Victoria Birlutiu, Prof. Dr.

  County Clinical Emergency Hospital of Sibiu

  STUDY CHAIR

• Adrian Boicean, Prof. Dr.

  County Clinical Emergency Hospital of Sibiu

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: August 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 31, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)