NCT05622526

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Group 1 or Experimental group	Capsules of fecal microbiota transplantation
OTHER	Group 2 or Control group	capsules of placebo

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-11-01
• Completion: 2026-03-01
• First posted: 2022-11-18
• Last updated: 2023-11-01