Gut bacteria boost may fight fatty liver

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged from 18 to 75 years old * BMI 25 - 42kg/m2 * Diagnosed with MASLD and CAP value \> 268 dB/m evaluated by FibroScan® * High ALT levels (\>30 U/L in males and \>19 U/L in females) * Having at least three of the following features compatible with metabolic syndrome: i. Waist circumference ≥ 102 cm in males and ≥ 88 cm in females. ii. Fasting serum glucose (≥ 5.6 mmol/L or 100 mg/dl). iii. Glycated haemoglobin (HbA1c ≥ 5.7%/ 39 mmol/L). iv. Diagnosed or treated for type 2 diabetes. v. High blood pressure (≥ 130/85 mmHg). vi. High plasma triglycerides (≥ 1.70 mmol/L or 150 mg/dl). vii. Lower plasma of High-Density Lipoprotein (HDL cholesterol) (≤ 1.0 mmol/L or 40 mg/dl for males and ≤ 1.3 mmol/L or 50 mg/dl for females). * Stable weight in the last 3 months (less than ± 4% weight variation). * Stable medication or intake of food supplements for a medical condition that can affect study outcomes according to the Investigator's judgement in the last three months prior to study entry (bile salt sequestrants are not permitted). * Not planning to change their dietary and lifestyle habits during the study. * Willing and able to provide informed consent and comply with study procedures. Exclusion Criteria: * Fibrosis scores equal or higher than F2 (≥ 8.0 kPa). * History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced liver diseases, severe liver diseases. * Prior or pending liver transplantation. Patients with at least one of the following concurrent conditions: i. Type I diabetes ii. Uncontrolled type II diabetes (HbA1c \>8%) iii. Hypertriglyceridemia \> 350mg/dl iv. Human Immunodeficiency Virus (HIV) infection v. Diagnosis of hemochromatosis * Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks. * Current use of bile salt sequestrants within 8 weeks. * Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac condition. * Pancreatic failure, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities) * Thyroid dysfunction, as assessed by the investigator (clinical criteria) * History of: i. Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease). ii. Cancer or immunosuppression. iii. Gastrointestinal surgery in the previous year (with the exception of appendicitis). * Patients with a history of chronic alcohol or drug abuse: \> 14 units/week for females and \> 21 units/week for male * Chronic and heavy smoking (\>20 cigarettes a day) * Regular intake (\> 3 days/week) of other probiotics (including food complements or diary foods with other probiotic strains, e.g. Activia®, Actimel® or similar). * Intake of nutraceuticals with an effect on hepatic function such as \> 500 mg/day omega-3 fatty acids, high-dose vitamin E supplements or milk thistle (sylibum marianum) extract ot their active ingredients (silymarin, silybin) regularly (\> 7 days) in the 15 days before study entry. * Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, MAOIs or second-generation antipsychotics, amiodarone, tamixofen and/or diltiazem. * History of use (\> 3 days) of oral or parenteral antibiotics one month before the study initiation. * Chronic use of laxatives. * Debilitating illnesses (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases). * Current pregnancy (positive urine test) or planning to become pregnant during the study. * Breastfeeding at the time of eligibility assessment. * Patients who have participated in a clinical trial in the six-month period before the study.