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

Prior treatment

• Major intra-abdominal surgery in the 2 months prior to the randomization of the patient in the study
• Intake of antibiotics in the 8 weeks prior to the screening date
• Intake of commercialized probiotics/prebiotics/symbiotic in the 4 weeks prior to the screening date
• Use of medication with a potential steatogenic effect (corticosteroids, valproic acid, amiodarone and/or tamoxifen) in the 6 months prior to the first dose of the study drug
• Weight loss of over 5% in the 3 months prior to the screening
• Diabetic patients with: •Insulin treatment. • Changes in the antidiabetic medicine in the 4 months prior to the liver biopsy according to the following conditions: -Dose modification of the treatment with Glucagon- like peptide-1 (GLP-1) agonists. -Implementation of the treatment with a new antidiabetic

Other illness

• Evidence of having another type of liver disease
• Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, kidney, liver, respiratory, inflammatory, or infectious disease, according to what the investigator determines
• Medical conditions that lower life expectancy to less than 2 years, including cancer
• Inflammatory bowel disease diagnosis (Crohn’s disease, ulcerative colitis, microscopic colitis), active irritable bowel syndrome (in the last 2 years according to the Rome IV criteria), celiac disease not well controlled with a gluten-free diet, active gastroparesis, toxic megacolon
• Any other condition that, according to the investigator, could impede or hinder compliance
• History of bariatric surgery
• Portal thrombosis

Lab values

• An estimated glomerular filtration rate (eGFR) <45 ml / min / 1,73 m2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration method [CKD-EPI])
• Subjects with HbA1c > 9,5%. In the case of subjects with an HbA1c > 9,5% during the selection visit, a repeated test can be performed during the window of selection. A repeated result of HbA1c > 9,5% shall result in exclusion

Other

• Presence of a hereditary or acquired immunodeficiency
• Pregnancy or breastfeeding
• High alcohol intake history (daily consumption > 30 g/day for men and > 20 g/day for women)
• Cirrhosis
• Known or suspected hepatocellular carcinoma

• Patients of both genders between 18-75 years of age (both included)
• Body mass index <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