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

Cristian Ichim19 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Fecal microbiota transplantationBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

County Clinical Emergency Hospital of Sibiu

Sibiu, Romania

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: At one month post-FMT.

Data from ClinicalTrials.gov

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