MedTrace Logo

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

NCT05622526 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-11-01

No results posted yet for this study

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

DRUG

Group 1 or Experimental group

Capsules of fecal microbiota transplantation

OTHER

Group 2 or Control group

capsules of placebo

Sponsors & Collaborators

  • Instituto de Investigación Marqués de Valdecilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-11-01
Completion
2026-03-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622526 on ClinicalTrials.gov