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COMPLETED
NCT07909772
NA

Effects of a Multispecies Probiotic on Metabolic, Liver, and Gut Health

Sponsor: University of Bari

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if multistrain probiotic works to improve severe metabolic markers and gastrointestinal symptoms in obese MASLD patients. The main questions it aims to answer are Does this multistrain probiotic improve the composition of gut microbiota? Does it improve gastrointestinal symptoms and metablic profiles? Does it help in improving the grade of liver steatosis, and lose weight? Researchers will compare a multistrain probiotic group to a control group. Participants will: The probiotic group will take multistrain probiotics daily for 6 months in addition to a dietary plan and physical activity recommendations. The control group will only follow a dietary plan and physical activity recommendations Visit the clinic every 3 months for checkups and be called every month for regular follow-ups

Official title: Effects of a Multispecies Probiotic on Metabolic Biomarkers, Liver Health, Inflammation, Gut Microbiota, and Gastrointestinal Symptoms: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-03-01

Completion Date

2026-07-30

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Multistrain Probiotic

The intervention consists of oral supplementation with a multispecies probiotic formulation. The product contains a blend of Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactococcus lactis W19, Lactococcus lactis W58, and a matrix of corn starch, maltodextrin, potassium chloride, hydrolyzed rice protein, magnesium sulfate, enzymes (amylase), and manganese sulfate. Participants will receive 3 grams administered once daily for 6 months. The formulation, dosage, administration schedule, and duration of supplementation define the intervention evaluated in this randomized clinical trial.

Locations (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, Bari (BA), Italy