Patients With Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer by Capsules vs. Placebo for the Treatment of Patients With Nonalcoholic Steatohepatitis
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.
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