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NOT YET RECRUITING
NCT06533852
PHASE3

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

Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

View on ClinicalTrials.gov

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

2024-12

Completion Date

2028-05

Last Updated

2024-08-01

Healthy Volunteers

No

Interventions

DRUG

Fecal Microbiome Transplantation (FMT)

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

OTHER

FMT Placebo

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