RecruitingPhase 3NCT06533852

Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis

Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis


Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Enrollment

190 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying FMT Placebo and a drug called Fecal Microbiome Transplantation (FMT) for people with decompensated cirrhosis. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal Microbiome Transplantation (FMT)

Two doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.

OTHERFMT Placebo

Two doses: First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months.


Locations(8)

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital General Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Corporació Sanitaria Universitaria Parc Taulí

Sabadell, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

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NCT06533852


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