Actively Recruiting
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
Led by AB Biotics, SA · Updated on 2026-04-30
60
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged from 18 to 75 years old
- Body mass index (BMI) between 25 and 42 kg/m2
- Diagnosed with MASLD and CAP value greater than 268 dB/m by FibroScan®
- Elevated ALT levels (>30 U/L in males and >19 U/L in females)
- Presence of at least three metabolic syndrome features: waist circumference ≥102 cm (males) or ≥88 cm (females), fasting glucose ≥5.6 mmol/L (100 mg/dl), HbA1c ≥5.7% (39 mmol/L), diagnosis or treatment of type 2 diabetes, high blood pressure (≥130/85 mmHg), high plasma triglycerides (≥1.70 mmol/L or 150 mg/dl), or low HDL cholesterol (≤1.0 mmol/L males, ≤1.3 mmol/L females)
- Stable weight for the last 3 months with less than ±4% variation
- Stable medication or supplement intake for medical conditions affecting study outcomes, excluding bile salt sequestrants, for at least 3 months prior
- No plans to change dietary or lifestyle habits during the study
- Willing and able to provide informed consent and comply with study procedures
You will not qualify if you...
- Fibrosis scores equal to or higher than F2 (≥8.0 kPa)
- History of acute or chronic hepatitis A, B, or C, autoimmune hepatitis, drug-induced liver diseases, or severe liver diseases
- Prior or pending liver transplantation
- Concurrent conditions including type I diabetes, uncontrolled type II diabetes (HbA1c >8%), hypertriglyceridemia >350 mg/dl, HIV infection, or 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 diseases such as inflammatory bowel disease, short bowel syndrome, chronic or recurrent diarrhea, or celiac disease
- Pancreatic failure or biliary dysfunction including cholecystectomy and abnormal bilirubin levels
- Thyroid dysfunction as assessed by the investigator
- History of cardiovascular disease, cancer, immunosuppression, or gastrointestinal surgery within the previous year (except appendicitis)
- History of chronic alcohol or drug abuse exceeding 14 units/week for females and 21 units/week for males
- Chronic heavy smoking (>20 cigarettes per day)
- Regular intake of other probiotics or nutraceuticals affecting liver function shortly before the study
- Current use of systemic corticosteroids, certain cardiac and psychiatric medications
- Recent use of oral or parenteral antibiotics within one month
- Chronic use of laxatives
- Debilitating illnesses such as advanced liver or kidney disease, severe depression, psychotic symptoms, or neurological diseases
- Current pregnancy or breastfeeding
- Participation in any clinical trial within the six months prior to this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitari Dr. Josep Trueta
Girona, Girona, Spain, 17190
Actively Recruiting
Research Team
J
José Manuel Dr. Fernández-Real, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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