An interventional study of Multistrain Probiotic in Metabolic-Associated Steatotic Liver Disease, Diabetes (DM) and Obesity & Overweight, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Bari · Not applicable, Interventional, and Supportive care
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
Patients were randomized for this study into two groups, Control group and Probiotic group. The study was designed as randomized trial with an intervention period of 6 months. Following baseline evaluations, eligible patients were randomly assigned in a 1:1 ratio to either the Control group or the Probiotic group.
All patients in both groups received standard dietary and physical activity recommendations tailored for metabolic health at the beginning of the study. The control group received only diet and physical activity recommendations for a 6-month period, while the probiotic group received, in addition, one daily dose of probiotic for the entire 6-month period, where each dose is 3 grams and contains a total of 7.5x109 CFU (colony-forming units) of a blend containing 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. The powder in the sachet was dissolved in 125 mL of water and drunk after a 1-minute activation time on an empty stomach before breakfast.
Patients were instructed to maintain their assigned regimens consistently. Compliance with probiotic intake and adherence to lifestyle recommendations were monitored during monthly follow-up calls.
Body weight was measured at baseline (T0) and at the end of the 6-month intervention period (T6), and height was measured to measure the body mass index (BMI, kg/m²). Waist and hip circumferences were recorded using a standardized flexible tape.
To evaluate liver steatosis grades and monitor metabolic-associated steatotic liver disease (MASLD), all patients underwent an ultrasound echography at T0 and T6. The ecographies were done by an experienced radiologist who remained blinded to the patients' group allocation to minimize bias.
GI symptoms were assessed at T0 and T6 using a validated Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, which tracks specific symptom clusters scored on a Likert scale.
Dietary habits were evaluated using the 14-item Mediterranean Diet Adherence Screener (MEDAS), a validated questionnaire. It consists of 14 questions regarding beneficial dietary habits, and each answer is awarded 1 point, resulting in a total score ranging from 0 to 14. A total score of ≥ 9 was considered indicative of high adherence to the Mediterranean diet.
Physical activity and sedentary behavior over the previous seven days were quantified using the short form of the International Physical Activity Questionnaire (IPAQ-SF).
Venous blood was collected from all patients at T0 and T6 in the morning after an overnight fast (around 10 hours). Serum and plasma were isolated by centrifugation (3000 rpm for 10 minutes) and immediately stored in aliquots at -80°C until analysis.
Plasma samples were transferred to a certified external laboratory for analysis to study the glycemic and lipid profiles as well as liver biomarkers and enzymatic activity.
Serum levels of inflammatory, anti-inflammatory, and oxidative stress were quantified at baseline (T0) and at 6 months (T6) using commercially available enzyme-linked immunosorbent assay (ELISA), in strict accordance with the manufacturer's protocols. All samples were analyzed in duplicate, and absorbance was measured using a microplate reader.
Stool samples were collected by patients at home using sterile collection kits, delivered to the laboratory, and frozen immediately at -80°C for subsequent analysis. To generate high-resolution taxonomic data, DNA extraction, 16S rRNA (ribosomal RNA) gene amplicon sequencing, and data processing were performed at the Joint Microbiome Facility of the Medical University of Vienna and the University of Vienna.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 3, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 grams of a multistrain probiotic was administered daily for 6 months in addition to a dietary plan and physical activity recommendations
Dietary Supplement: Multistrain Probiotic
A dietary plan and physical activity recommendations was followed for 6 months
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.
Mean Change From Baseline in Body Mass Index (BMI) at 6 Months
Body Mass Index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Waist Circumference at 6 Months
Waist circumference measured in centimeters (cm) to assess central adiposity.
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Hip Circumference at 6 Months
Hip circumference measured in centimeters (cm).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 6 Months
Fasting plasma glucose levels are measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
Glycated hemoglobin percentage is measured as a total proportion of hemoglobin (mmol/mol).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Fasting Insulin Levels at 6 Months
Fasting serum insulin levels are measured in micromoles per milliliter (μIU/mL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index at 6 Months
The minimum possible score is 0, with no set maximum value. Higher scores indicate a worse outcome (greater insulin resistance).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Total Cholesterol at 6 Months
Total serum cholesterol levels measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at 6 Months
High-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at 6 Months
Low-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Triglycerides at 6 Months
Serum triglyceride levels measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Aspartate Aminotransferase (AST) Activity at 6 Months
Serum aspartate aminotransferase enzymatic activity levels are measured in units per liter (U/L).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Alanine Aminotransferase (ALT) Activity at 6 Months
Serum alanine aminotransferase enzymatic activity levels were measured in units per liter (U/L).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Gamma-Glutamyl Transferase (γ-GT) Activity at 6 Months
Serum gamma-glutamyl transferase enzymatic activity levels were measured in units per liter (U/L).
Time frame: Baseline (T₀) and 6 months (T₆)
Alpha Diversity (Shannon Index)
Alpha diversity of the gut microbiota assessed using the Shannon Index derived from 16S rRNA sequencing of fecal samples. The Shannon Index accounts for both abundance and evenness of the microbial species present. The scale ranges from a minimum value of 0 to a maximum value of approximately 5 or higher. Higher index values indicate a better outcome (greater gut microbiota diversity and evenness).
Time frame: Baseline (T₀) and 6 months (T₆)
Change From Baseline in Gut Microbiota Alpha Diversity (Chao1 Index) at 6 Months
Alpha diversity of the gut microbiota was assessed using the Chao1 Index derived from 16S rRNA sequencing of fecal samples. The Chao1 index estimates total species richness. The index ranges from a minimum value of 0 with no defined maximum score. Higher index values indicate a better outcome (greater microbial species richness).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels at 6 Months
Serum concentrations of the inflammatory cytokine tumor necrosis factor-alpha (TNF-α), measured in picograms per milliliter (pg/mL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-10 (IL-10) Levels at 6 Months
Serum concentrations of the anti-inflammatory cytokine Interleukin-10 (IL-10), measured in picograms per milliliter (pg/mL)
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-1 Beta (IL-1β) Levels at 6 Months
Serum concentrations of the inflammatory cytokine Interleukin-1 Beta (IL-1β), measured in picograms per milliliter (pg/mL).
Time frame: baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-6 (IL-6) Levels at 6 Months
Serum concentrations of the inflammatory cytokine Interleukin-6 (IL-6), measured in picograms per milliliter (pg/mL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Fatty Acid-Binding Protein 2 (FABP2) Levels at 6 Months
Serum concentrations of Fatty Acid-Binding Protein 2 (FABP2) to evaluate intestinal epithelial cell injury, measured in picograms per milliliter (pg/mL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Plasma Lipopolysaccharide (LPS) Levels at 6 Months
Plasma concentrations of lipopolysaccharide (LPS) to evaluate metabolic endotoxemia, measured in endotoxin units per milliliter (EU/mL)
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Zonulin Levels at 6 Months
Serum concentrations of zonulin to evaluate intestinal permeability, measured in nanograms per milliliter (ng/mL).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at 6 Months
Gastrointestinal symptoms were assessed using the GSRS questionnaire. The GSRS contains 21 items clustered into 5 symptom subscales. Each item is rated on a 7-point Likert scale. The total score is calculated as the average of all items, ranging from a minimum score of 1 (no symptoms) to a maximum score of 7 (severe symptoms). Higher scores indicate a worse outcome (greater gastrointestinal symptom severity).
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Hepatic Steatosis Grade at 6 Months
Hepatic steatosis severity evaluated via transabdominal ultrasound. Steatosis is graded on a standard 4-point clinical scale: Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe). Total scores range from a minimum of 0 to a maximum of 3. Higher grades indicate a worse outcome (greater severity of hepatic steatosis).
Time frame: Baseline (T₀) and 6 months (T₆)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bari