Actively Recruiting
Investigation of the Efficacy of a Probiotic Mixture in Subjects With 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 75 with moderate metabolic dysfunction-associated steatotic liver disease (MASLD) to see if a specific probiotic mix can improve liver health. The trial focuses on whether the probiotic affects liver fat and stiffness using non-invasive imaging methods like FibroScan® CAP and FAST scores, and also examines changes in cholesterol, blood sugar, inflammation, and gut bacteria. Participants have metabolic conditions alongside MASLD and stable weight and medications. Participants will be randomly assigned to take either a daily probiotic capsule containing three strains of Lactiplantibacillus plantarum or a placebo capsule without active ingredients for 6 months. The probiotic is designed to influence gut microbiota and liver health. The study is double-blind and involves three visits at the start, 3 months, and 6 months for treatment and monitoring. During the study, participants will undergo liver scans, provide blood and stool samples, and complete health and nutrition questionnaires. Researchers will track changes in liver condition, metabolic markers, body measurements, blood pressure, and various blood tests related to liver function, inflammation, metabolism, and gut microbiota diversity. The main outcomes are measured from enrollment up to 6 months, with safety and effectiveness monitored throughout.
CONDITIONS
Brief 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 (above 30 U/L in males, above 19 U/L in females)
- At least three features of metabolic syndrome such as waist circumference, fasting glucose, HbA1c, type 2 diabetes, high blood pressure, high triglycerides, or low HDL cholesterol
- Stable weight in the last 3 months (less than ±4% variation)
- Stable medication or supplements affecting study outcomes for the last 3 months (except bile salt sequestrants)
- Not planning to change diet or lifestyle during the study
- Willing and able to provide informed consent and follow study procedures
You will not qualify if you...
- Fibrosis scores equal or higher than F2 (≥ 8.0 kPa)
- History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced or severe liver diseases
- Prior or pending liver transplantation
- Type I diabetes or uncontrolled type II diabetes (HbA1c > 8%)
- Hypertriglyceridemia over 350 mg/dl
- HIV infection or diagnosis of hemochromatosis
- Current use of certain drugs for MASLD or steatohepatitis, bile salt sequestrants within 8 weeks
- Significant gastrointestinal diseases like inflammatory bowel disease or chronic diarrhea
- Pancreatic failure or biliary dysfunction
- Thyroid dysfunction as assessed by the investigator
- History of cardiovascular disease, cancer, immunosuppression, or recent gastrointestinal surgery
- History of chronic alcohol or drug abuse exceeding specified limits
- Heavy smoking (more than 20 cigarettes a day)
- Regular intake of other probiotics or certain nutraceuticals before study entry
- Use of systemic corticosteroids, specific medications, or antibiotics recently
- Chronic use of laxatives
- Debilitating illnesses including advanced liver or kidney disease, severe depression, psychosis, or neurological diseases
- Current pregnancy or breastfeeding
- Participation in another clinical trial within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take a daily oral probiotic capsule or placebo to modulate gut microbiota and improve liver health in MASLD patients.
Regular visits throughout treatment to assess health and response
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
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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