Status:
NOT_YET_RECRUITING
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
Lead Sponsor:
AB Biotics, SA
Conditions:
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Fatty Liver Disease, Nonalcoholic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD). ...
Eligibility Criteria
Inclusion
- Patients aged from 18 to 65 years old
- BMI 25.34,9kg/m2
- Diagnosed with MASLD and CAP value \> 268 dB/m evaluated by FibroScan®
- High ALT levels (\>43 U/L in males and \>33 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
- Fibrosis scores equal or higher than F2 (≥ 7.5 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.
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07193927
Start Date
October 13 2025
End Date
June 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
Hospital Universitari Dr. Josep Trueta
Girona, Girona, Spain, 17190