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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06478602

Enrollment

Registered

2024-06-27

Start date

2024-08-05

Completion date

2025-03-31

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

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

Brief summary

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

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).

Interventions

BIOLOGICALFecal microbiota transplantation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Liver Stiffness by Transient Elastography (FibroScan)	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	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.

Countries

Romania

Contacts

STUDY_CHAIRVictoria Birlutiu, Prof. Dr.

County Clinical Emergency Hospital of Sibiu

STUDY_DIRECTORAdrian Boicean, Prof. Dr.

County Clinical Emergency Hospital of Sibiu

Participant flow

Recruitment details

Patients were recruited from the Sibiu County Emergency Clinical Hospital, Romania. Inclusion Criteria: * Diagnosis of liver cirrhosis according to current protocols. * Conscious and cooperative adult patients.

Pre-assignment details