Study of the faecal microbiota transfer in capsule form vs. placebo for the treatment of patients with non-alcoholic steatohepatitis

INTERVENTION: Product Name: microcrystalline cellulose Ph Eur, in hypromellose capsules,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: Lyophilized capsules of fecal microbiota,Product Code: PRD9559185,Pharmaceutical Form: CAPSULE,Strength: Allogeneic Faecal Microbiota, Pooled 0.052teraOrganisms...0.062teraOrganisms,Current Sponsor code: MBK‐01 CONDITION: MedDRA version: 22.0Level: PTClassification code: 10053219Term: Non‐alcoholic steatohepatitisSystem Organ Class: 100000004871 non‐alcoholic steatohepatitis ; MedDRA version: 22.0Level: PTClassification code: 10053219Term: Non‐alcoholic steatohepatitisSystem Organ Class: 100000004871 Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective:‐ Assess the efficiency of the FMT in capsule form compared to the placebo regarding liver improvement passed 72 weeks in patients with NASH.‐ Assess the security and tolerability of the FMT in capsule form in patients with NASH during 72 weeks of treatment. Primary end point(s):‐Patient ratio with a NASH resolution without fibrosis worsening. ‐Patient ratio without fibrosis nor activity worsening. ‐Patient ratio with a MRI‐PDFF betterment and without a fibrosis or activity worsening.,Occurrence of adverse events (AE), severe AE (SAE), AE that result in the interruption of the study’s treatment, AE of special interest, and changes in the vital signs and the laboratory results during 72 weeks of treatment Secondary Objective:Assess the NASH changes in the liver histology with the FMT in capsule form in comparison to the placebo after 72 weeks.,Assess the effect of the FMT in capsule form compared to the placebo regarding the liver fibrosis measured by changes in non‐invasive markers.,Assess the effect of the FMT in capsule form compared to the placebo on the fat content.,Determine the effect of the FMT in capsule form on different metabolic factors after 72 weeks of treatment.,Determine the effect of the FMT in capsule form on the cardiovascular risk (CVR) after 72 weeks of treatment.,Assess the effect of the FMT in capsule form on the health results perceived by the patients. SECONDARY OUTCOME: Secondary end point(s):Changes in anthropometric measurements Secondary end point(s):Changes in emerging CVR factors Secondary end point(s):Changes in fibrosis biomarkers Secondary end point(s):Changes in inflammation biomarkers Secondary end point(s):Changes in insulin resistance Secondary end point(s):Changes in lipid profile Secondary end point(s):Changes in the carotid ultrasound Secondary end point(s):Changes in the CLDQ‐NAFLD questionnaire Secondary end point(s):Changes in the SF‐36 questionnaire Secondary end point(s):Changes in vital signs Secondary end point(s):MRI‐PDFF Secondary end point(s):Patient ratio with betterment regarding the lobular inflammation and/or ballooning without fibrosis worsening INCLUSION CRITERIA: Patients of both genders between 18‐75 years of age (both included),Body mass inde X<40 kg/m2,NASH histological diagnosis, accepted by the EASL and the AASLD, of a liver biopsy obtained up to 24 weeks prior to signing the informed consent form,NASH histological activity score (NAS) = 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation and bulging of liver cells),Histological evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 fibrosis (perisinusoidal and portal/periportal fibrosis) or stage 3 fibrosis (bridging fibrosis) as defined by the NASH CRN fibrosis score,In the case of women and men of childbearing age, for safety, those who agree to follow the required contraceptive measures after signing the informed consent form until the first visit of the follow‐up period