Metabolic-Associated Steatotic Liver DiseaseGUT-MET 2026NCT07909772
Effects of a Multispecies Probiotic on Metabolic, Liver, and Gut Health
A study testing Multistrain Probiotic in people with Metabolic-Associated Steatotic Liver Disease and Diabetes (DM), run by University of Bari at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic-Associated Steatotic Liver Disease, Diabetes (DM), Obesity & Overweight
- What is being tested?
- Multistrain Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were either diagnosed with MASLD,
- had a body mass index of 25 kg/m² or more
- had gastrointestinal symptoms,
- had not taken antibiotics or probiotics for the last three months
Who cannot join
- patients who were already on antibiotic treatment or had been taking probiotics within the last three months
- pregnant or lactating women,
- suffering from severe cardiovascular, renal, or hepatic medical conditions.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
Bari, Bari (BA), 70124
About this study
Official title: Effects of a Multispecies Probiotic on Metabolic Biomarkers, Liver Health, Inflammation, Gut Microbiota, and Gastrointestinal Symptoms: A Randomized Clinical Trial
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.
Read more
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
Read the detailed description
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.
- Being tested
- Multistrain Probiotic
- Keywords
- multistrain probiotic, gut microbiota, intestinal permeability, obesity, MASLD
- Medical subject headings
- Diabetes Mellitus, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multistrain ProbioticDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 3 grams of a multistrain probiotic was administered daily for 6 months in addition to a dietary plan and physical activity recommendations Receives: Dietary Supplement: Multistrain Probiotic |
| Control Group | No intervention | A dietary plan and physical activity recommendations was followed for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Hip Circumference at 6 Months
Hip circumference measured in centimeters (cm).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (T₀) and 6 months (T₆)
Secondary outcomes (9)
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (T₀) and 6 months (T₆)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Mar 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909772
- Sponsor's protocol ID
- GutMet
- Acronym
- GUT-MET 2026
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multispecies Probiotic on Metabolic Biomarkers, Liver Health, Inflammation, Gut Microbiota, and Gastrointestinal Symptoms: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07909772
- Acronym / sponsor ID
- GUT-MET 2026 / GutMet
- Keywords
- multistrain probiotic, gut microbiota, intestinal permeability, obesity, MASLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Multistrain Probiotic3 grams of a multistrain probiotic was administered daily for 6 months in addition to a dietary plan and physical activity recommendations |
| Control Group | No intervention | –A dietary plan and physical activity recommendations was followed for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients were either diagnosed with MASLD,
- had a body mass index of 25 kg/m² or more
- had gastrointestinal symptoms,
- had not taken antibiotics or probiotics for the last three months
Key exclusion criteria (3 listed)
- patients who were already on antibiotic treatment or had been taking probiotics within the last three months
- pregnant or lactating women,
- suffering from severe cardiovascular, renal, or hepatic medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multistrain ProbioticThe 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. | Dietary supplement | Intervention Group |
Primary outcome
Mean Change From Baseline in Body Mass Index (BMI) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Body Mass Index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m²).
Mean Change From Baseline in Waist Circumference at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Waist circumference measured in centimeters (cm) to assess central adiposity.
Mean Change From Baseline in Hip Circumference at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Hip circumference measured in centimeters (cm).
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Fasting plasma glucose levels are measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Glycated hemoglobin percentage is measured as a total proportion of hemoglobin (mmol/mol).
Mean Change From Baseline in Fasting Insulin Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Fasting serum insulin levels are measured in micromoles per milliliter (μIU/mL).
Mean Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
The minimum possible score is 0, with no set maximum value. Higher scores indicate a worse outcome (greater insulin resistance).
Mean Change From Baseline in Total Cholesterol at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Total serum cholesterol levels measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
High-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Low-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline in Triglycerides at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Serum triglyceride levels measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline in Aspartate Aminotransferase (AST) Activity at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Serum aspartate aminotransferase enzymatic activity levels are measured in units per liter (U/L).
Mean Change From Baseline in Alanine Aminotransferase (ALT) Activity at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Serum alanine aminotransferase enzymatic activity levels were measured in units per liter (U/L).
Mean Change From Baseline in Gamma-Glutamyl Transferase (γ-GT) Activity at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Serum gamma-glutamyl transferase enzymatic activity levels were measured in units per liter (U/L).
Alpha Diversity (Shannon Index)
Time frame: Baseline (T₀) and 6 months (T₆)
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).
Change From Baseline in Gut Microbiota Alpha Diversity (Chao1 Index) at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
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).
9 secondary outcomes
Mean Change From Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-10 (IL-10) Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-1 Beta (IL-1β) Levels at 6 Months
Time frame: baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Interleukin-6 (IL-6) Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Fatty Acid-Binding Protein 2 (FABP2) Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Plasma Lipopolysaccharide (LPS) Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Serum Zonulin Levels at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Mean Change From Baseline in Hepatic Steatosis Grade at 6 Months
Time frame: Baseline (T₀) and 6 months (T₆)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multistrain Probiotic in people with Metabolic-Associated Steatotic Liver Disease and Diabetes (DM), run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Body Mass Index (BMI) at 6 Months (time frame: Baseline (T₀) and 6 months (T₆)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.