ALLOGENEIC FAECAL MICROBIOTA, POOLED for Non-alcoholic steatohepatitis

Inclusion criteria

• {"criterion_text":"-Patients of both genders between 18-75 years of age (both included)\n-Body mass index <40 kg/m2\n-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\n-NASH histological activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation and bulging of liver cells)\n-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\n-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"}

Exclusion criteria

• {"criterion_text":"-Evidence of having another type of liver disease\n-Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, kidney, liver, respiratory, inflammatory, or infectious disease, according to what the investigator determines\n-An estimated glomerular filtration rate (eGFR) <45 ml / min / 1,73 m2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration method [CKD-EPI])\n-Medical conditions that lower life expectancy to less than 2 years, including cancer\n-Presence of a hereditary or acquired immunodeficiency\n-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\n-Major intra-abdominal surgery in the 2 months prior to the randomization of the patient in the study\n-Intake of antibiotics in the 8 weeks prior to the screening date\n-Intake of commercialized probiotics/prebiotics/symbiotic in the 4 weeks prior to the screening date\n-Pregnancy or breastfeeding\n-Any other condition that, according to the investigator, could impede or hinder compliance\n-High alcohol intake history (daily consumption > 30 g/day for men and > 20 g/day for women)\n-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\n-Weight loss of over 5% in the 3 months prior to the screening\n-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\n-Diabetic patients with: •Insulin treatment. •\tChanges 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\n-History of bariatric surgery\n-Cirrhosis\n-Portal thrombosis\n-Known or suspected hepatocellular carcinoma"}

Primary endpoints

• {"endpoint_text":"-Patient ratio with a NASH resolution without fibrosis worsening.\n-Patient ratio without fibrosis nor activity worsening.\n-Patient ratio with a MRI-PDFF betterment and without a fibrosis or activity worsening.","definition_or_measurement_approach":"Assessed after 72 weeks of treatment (as stated in main objective and duration)."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Occurrence measured and reported during 72 weeks of treatment (standard AE/SAE reporting and monitoring of vital signs and laboratory results)."}

Secondary endpoints

• {"endpoint_text":"-Patient ratio with betterment regarding the lobular inflammation and/or ballooning without fibrosis worsening","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in fibrosis biomarkers","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-MRI-PDFF","definition_or_measurement_approach":"MRI-PDFF imaging measurement"}
• {"endpoint_text":"-Changes in anthropometric measurements","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in lipid profile","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in inflammation biomarkers","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in insulin resistance","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in vital signs","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in emerging CVR factors","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in the carotid ultrasound","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"-Changes in the SF-36 questionnaire","definition_or_measurement_approach":"Patient-reported SF-36 questionnaire changes; specifics not detailed"}
• {"endpoint_text":"-Changes in the CLDQ-NAFLD questionnaire","definition_or_measurement_approach":"Patient-reported CLDQ-NAFLD questionnaire changes; specifics not detailed"}

Spain

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

17-02-2025

Processing Time Days

105

Number Of Sites

2

Number Of Participants

1

Primary sponsor

Full Name

Mikrobiomik Healthcare Company S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Sermes Planificacion S.L.

Responsibilities

sponsorDuties codes: 1,10,11,12,5,6,8; contact email start-up@sermescro.com; phone 0034913756930

Third parties

• {"country":"Spain","full_name":"Sermes Planificacion S.L.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6,8; contact phone 0034913756930; email start-up@sermescro.com","organisation_type":"Pharmaceutical company"}