Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated… (NCT07193927) | Clinical Trial Compass
RecruitingPhase 2
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
Spain60 participantsStarted 2026-03-20
Plain-language 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).
The main questions it aims to answer are:
Can the probiotics improve liver fat and stiffness as measured by non-invasive imaging (FibroScan® CAP and FAST scores)? Does the probiotic affect other health markers like cholesterol, blood sugar, inflammation, and gut bacteria?
Researchers will compare people taking the probiotic to those taking a placebo (a capsule with no active ingredients) to see if the probiotic has beneficial effects.
Participants will:
Be randomly assigned to take either the probiotic or placebo daily for 6 months.
Attend 3 study visits (at the start, 3 months, and 6 months). Provide blood and stool samples. Undergo liver scans (FibroScan®). Complete a health and nutrition questionnaire.
This study includes adults aged 18-65 with moderate MASLD and certain metabolic health conditions. Participants must not be pregnant, breastfeeding, or taking certain medications or supplements that could interfere with the study.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 leas…
What they're measuring
1
Changes in MASLD from baseline
Timeframe: From enrollment to the end of treatment at 6 months.