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.
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)
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.
Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.
Parallel
Lactiplantibacillus plantarum Probiotic Mixture
Dietary supplementA daily oral probiotic capsule containing three specific strains of Lactiplantibacillus plantarum (KABP011, KABP012, KABP013) 1,2 billion CFU with vitamin B1, designed to modulate gut microbiota and improve liver health in MASLD patients. It is compared to a placebo in a 6-month, double-blind, mechanistic trial.
Placebo comparator containing maltodextrin
Dietary supplementPlacebo comparator containing maltodextrin
Changes in MASLD from baseline
Evaluated by CAP (controlled attenuation parameter, dB/m) and FAST score \[determined with FibroScan®\]
Changes from baseline in Liver Fibrosis (kPa)
Changes form baseline in MASLD related index - FLI
Evaluated by Fatty Liver Index (FLI)
Changes form baseline in MASLD related index - FIB-4
Evaluated by Fibrosis 4 score (FIB-4)
Changes form baseline in MASLD related index - APRI
Evaluated by Aspartate aminotransferase-to-platelet ratio index (APRI)
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