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

NCT05622526•Instituto de Investigación Marqués de Valdecilla

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of both genders aged between 18 and75 years old (both included).
•2. Body mass index (BMI) \<40 kg/m2.
•3. Histological diagnosis of NASH, accepted by EASL and AASLD , from a liver biopsy obtained up to 24 weeks prior to the signing of the informed consent.
•4. NASH histologic activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation, and liver cell ballooning).
•5. Histologic evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 (perisinusoidal and portal/periportal fibrosis), or stage 3 (bridging fibrosis) as defined by the NASH CRN fibrosis score.

Exclusion Criteria

•1. Evidence of other type of liver disease.
•2. History of high alcohol intake (daily consumption \> 30 g/day for men and \> 20 g/day for women).
•3. Weight change of more than 5% in the 3 months prior to screening.
•4. Subjects with HbA1c\> 9.5%. For subjects with an HbA1c\> 9.5% at the screening visit, a repeat test may be performed within the screening window.
•A repeated result of HbA1c\> 9.5% will result in exclusion.
•5. Diabetic patients with:
•* Insulin treatment.
•* Changes in antidiabetic medication in the 4 months prior to liver biopsy according to the following conditions:
•* Modification of the dose of treatment with glucagon agonists type 1 (GLP-1).
•* Implementation of treatment with a new antidiabetic.
+15 more criteria

Key Dates

Start Date

January 1, 2024

Primary Completion Date

November 1, 2025

Completion Date

March 1, 2026

Last Updated

November 1, 2023

Enrollment

ESTIMATED participants

Conditions

Patients With Nonalcoholic Steatohepatitis

Interventions

Group 1 or Experimental group

DRUG

Group 2 or Control group

OTHER

Contacts

Javier Crespo

CONTACT

942315515 javiercrespo1991@gmail.com

Paula Iruzubieta

CONTACT

942315515 paula.iruzubieta@scsalud.es