NCT06533852

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decompensated Cirrhosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-08-01
• Last updated: 2024-08-01