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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Capsules of fecal microbiota transplantation
capsules of placebo
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
Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.
Time frame: 72 weeks
NAFLD Fibrosis score
Time frame: 72 weeks
Changes in weight, BMI.
Time frame: 72 weeks
Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.
Time frame: 72 weeks
Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.
Time frame: 72 weeks
patient-reported outcomes
Time frame: 72 weeks
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