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

Cristian Ichim

Status and phase: Enrolling; Phase 3

Conditions: Liver Cirrhosis

Treatments: Biological: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06478602

No: 3505/15.02.2023

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Fecal microbiota transplantation (FMT) in patients with liver cirrhosis

Experimental group

Description:

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.

Treatment:

Biological: Fecal microbiota transplantation

Control

No Intervention group

Description:

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