Overview

Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer for the Treatment of Patients With Nonalcoholic Steatohepatitis

Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
The EMOTION study is a multicentric, double-blind, controlled, parallel-group, phase IIa randomized Clinical trial to evaluate the efficacy, safety and tolerability of TMF capsules for the treatment of patients with NASH. The clinical trial has two stages: - Screening phase with a duration of 12 weeks to classify patients based on lifestyle modifications. - Treatment phase where patients will be randomized and stratified 2:1 to treatment: - Experimental for n=64 patients. - Placebo control for n=32 patients.
Phase:
Phase 2
Details
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla