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

Instituto de Investigación Marqués de Valdecilla0 sites96 target enrollmentJanuary 1, 2024

ConditionsPatients With Nonalcoholic Steatohepatitis

InterventionsGroup 1 or Experimental group Group 2 or Control group

DrugsGroup 1 or Experimental group

Overview

Phase: Phase 2
Intervention: Group 1 or Experimental group
Conditions: Patients With Nonalcoholic Steatohepatitis
Sponsor: Instituto de Investigación Marqués de Valdecilla
Enrollment: 96
Primary Endpoint: Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

March 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto de Investigación Marqués de Valdecilla

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of both genders aged between 18 and75 years old (both included).
•Body mass index (BMI) \<40 kg/m
•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.
•NASH histologic activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation, and liver cell ballooning).
•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

•Evidence of other type of liver disease.
•History of high alcohol intake (daily consumption \> 30 g/day for men and \> 20 g/day for women).
•Weight change of more than 5% in the 3 months prior to screening.
•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.
•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.

Arms & Interventions

Group 1 or Experimental group

treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months (4 maintenance doses).

Intervention: Group 1 or Experimental group

Group 2 or Control group

treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months for 12 months (4 maintenance doses)

Intervention: Group 2 or Control group

Outcomes

Primary Outcomes

Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.

Time Frame: 72 weeks

number of adverse events (AEs), serious AEs, AEs resulting in discontinuation of study treatment, AEs of special interest, and changes in vital signs and laboratory values

Time Frame: 72 weeks

Secondary Outcomes

Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.(72 weeks)
NAFLD Fibrosis score(72 weeks)
Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.(72 weeks)
Changes in weight, BMI.(72 weeks)
Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.(72 weeks)
patient-reported outcomes(72 weeks)