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Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
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.
Official title: Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2025-07-16
Completion Date
2029-01
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Fecal Microbiome Transplantation (FMT)
Two doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.
FMT 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