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

NCT05622526 | Not Yet Recruiting Phase 2

• 1 other identifier: EMOTION
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients With Nonalcoholic Steatohepatitis

Keywords

MetEH: metabolic hepatic steatosis; NASH nonalcoholic steatohepatitis; TMF: fecal microbiota transplantation

Outcome Measures

Primary Outcomes (2)

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

  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

  72 weeks

Secondary Outcomes (6)

• 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 weight, BMI.

  72 weeks

• Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.

  72 weeks

• Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.

  72 weeks

Study Arms (2)

Group 1 or Experimental group

EXPERIMENTAL

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).

Drug: Group 1 or Experimental group

Group 2 or Control group

PLACEBO COMPARATOR

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)

Other: Group 2 or Control group

Interventions

Group 1 or Experimental group DRUG

Capsules of fecal microbiota transplantation

Group 1 or Experimental group

Group 2 or Control group OTHER

capsules of placebo

Group 2 or Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders aged between 18 and75 years old (both included).
• Body mass index (BMI) \<40 kg/m2.
• 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.

You may not qualify if:

• 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.
• 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.
• History of bariatric surgery.
• Cirrhosis.
• Portal thrombosis.
• Known or suspected hepatocellular carcinoma.
• Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease, as determined by the investigator.
• An estimated glomerular filtration rate (eGFR) \<45 ml / min / 1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] method).

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Javier Crespo

CONTACT

942315515; javiercrespo1991@gmail.com

Paula Iruzubieta

CONTACT

942315515; paula.iruzubieta@scsalud.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: November 18, 2022
• Study Start: January 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10