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

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.

Timeline

Start

2024-01-01

Primary completion

2025-11-01

Completion

2026-03-01

Drugs

Indications