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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
2024-12
Completion Date
2028-05
Last Updated
2024-08-01
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.