MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 2NCT07193927
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
A Phase 2 study testing Lactiplantibacillus plantarum Probiotic Mixture in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Fatty Liver Disease, Nonalcoholic, run by AB Biotics, SA at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic, Overweight (BMI > 25)
- What is being tested?
- Lactiplantibacillus plantarum Probiotic Mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2026to 1 Jun 2027
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Having at least three of the following features compatible with metabolic syndrome:
- Waist circumference ≥ 102 cm in males and ≥ 88 cm in females. ii. Fasting serum glucose (≥ 5.6 mmol/L or 100 mg/dl). iii. Glycated haemoglobin (HbA1c ≥ 5.7%/ 39 mmol/L). iv. Diagnosed or treated for type 2 diabetes. v. High blood pressure (≥ 130/85 mmHg). vi. High plasma triglycerides (≥ 1.70 mmol/L or 150 mg/dl). vii. Lower plasma of High-Density Lipoprotein (HDL cholesterol) (≤ 1.0 mmol/L or 40 mg/dl for males and ≤ 1.3 mmol/L or 50 mg/dl for females).
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- Stable weight in the last 3 months (less than ± 4% weight variation).
- Stable medication or intake of food supplements for a medical condition that can affect study outcomes according to the Investigator's judgement in the last three months prior to study entry (bile salt sequestrants are not permitted).
- Not planning to change their dietary and lifestyle habits during the study.
- Willing and able to provide informed consent and comply with study procedures.
Who cannot join
- 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.
- Patients with at least one of the following concurrent conditions:
- Type I diabetes ii. Uncontrolled type II diabetes (HbA1c >8%) iii. Hypertriglyceridemia > 350mg/dl iv. Human Immunodeficiency Virus (HIV) infection v. Diagnosis of hemochromatosis
- Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.
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- Current use of bile salt sequestrants within 8 weeks.
- Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac condition.
- Pancreatic failure, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)
- Thyroid dysfunction, as assessed by the investigator (clinical criteria)
- History of:
- Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease).
- Cancer or immunosuppression. iii. Gastrointestinal surgery in the previous year (with the exception of appendicitis).
- Patients with a history of chronic alcohol or drug abuse: > 14 units/week for females and > 21 units/week for male
- Chronic and heavy smoking (>20 cigarettes a day)
- Regular intake (> 3 days/week) of other probiotics (including food complements or diary foods with other probiotic strains, e.g. Activia®, Actimel® or similar).
- Intake of nutraceuticals with an effect on hepatic function such as > 500 mg/day omega-3 fatty acids, high-dose vitamin E supplements or milk thistle (sylibum marianum) extract ot their active ingredients (silymarin, silybin) regularly (> 7 days) in the 15 days before study entry.
- Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, MAOIs or second-generation antipsychotics, amiodarone, tamixofen and/or diltiazem.
- History of use (> 3 days) of oral or parenteral antibiotics one month before the study initiation.
- Chronic use of laxatives.
- Debilitating illnesses (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).
- Current pregnancy (positive urine test) or planning to become pregnant during the study.
- Breastfeeding at the time of eligibility assessment.
- Patients who have participated in a clinical trial in the six-month period before the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta
Girona, Girona, 17190
José Manuel Fernández Real Dr., +34 972940200 - 2656, jmfreal@idibgi.org
About this study
Official title: Investigation of the Efficacy of a Probiotic Mixture in Subjects With Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
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:
Read more
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.
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic, Overweight (BMI > 25)
- Being tested
- Lactiplantibacillus plantarum Probiotic Mixture, Placebo comparator containing maltodextrin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactiplantibacillus plantarum Probiotic MixtureDietary supplement
A 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 maltodextrinDietary supplement
Placebo comparator containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Lactiplantibacillus plantarum Probiotic Mixture |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo comparator containing maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MASLD from baseline
Evaluated by CAP (controlled attenuation parameter, dB/m) and FAST score [determined with FibroScan®]
Measured: From enrollment to the end of treatment at 6 months.
Secondary outcomes (28)
Changes from baseline in Liver Fibrosis (kPa)
Measured: From enrollment to the end of treatment at 6 months.
Changes form baseline in MASLD related index - FLI
Evaluated by Fatty Liver Index (FLI)
Measured: From enrollment to the end of treatment at 6 months.
Changes form baseline in MASLD related index - FIB-4
Evaluated by Fibrosis 4 score (FIB-4)
Measured: From enrollment to the end of treatment at 6 months.
Changes form baseline in MASLD related index - APRI
Evaluated by Aspartate aminotransferase-to-platelet ratio index (APRI)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in metabolic syndrome score (siMS)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in weight (kg)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in height (cm)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in Body Mass Index (BMI)
Body Mass Index (BMI) is a person's weight (kg) divided by the square of height (m).
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in waist circumference (cm)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in hip circumference (cm)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in waist/hip ratio
Waist/hip ratio is measured as the waist circumference (cm) divided by the hip circumference (cm).
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in systolic and diastolic blood pressure.
Measured: From entollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of blood-based cell profile.
Blood count red cell line, white cell line, and platelet line.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum liver enzyme concentrations
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), alkaline phosphatase (AP)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis insulin resistance-related variables
Fasting serum glucose, insulin, glycosylated haemoglobin (HbA1c)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of cholesterol and fatty acid concentrations:
Total cholesterol, low-density lipoprotein, high-density lipoprotein, cholesterol, triglycerides.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of high-sensitivity C-reactive protein (hsCRP) concentration.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of albumin concentration
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of total bilirubin (TBIL)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of kidney function biomarkers
Uric acid, creatinine (CREA), and blood urea nitrogen (BUN)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of thyroid hormones
Thyrotropin (TSH), thyroxine (T4), triiodothyronine (T3), parathyroid hormone (PTH)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of iron binding capacity
Ferritin, transferrin, binding capacity
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of electrolytes
Sodium (Na), potassium (K), chloride (Cl)
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of estimated glomerular filtration rate
Estimated glomerular filtration rate (eGFR) measurements developed by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration research group.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum analysis of nutritional and metabolic biomarkers
Magnesium (Mg), phosphate (P), iron (Fe), calcium (Ca), total protein, cortisol, 25-hydroxyvitamin D.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in serum metabolite profile by Elevated Global metabolome analysis (amine/phenol and acid channels CIL LC-MS profiling)
Quantification of metabolites (around 850 or more), with a minimum confidence of 90% in the identifications.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in gut microbiota diversity
Evaluated through shot gun metagenomics 10GB/spl (Sample QC + Nextera DNA XT (META) Library and NovaSeqX150PE 10 Gb/sample.
Measured: From enrollment to the end of treatment at 6 months.
Changes from baseline in gut microbiota relative abundance
Evaluated through shot gun metagenomics 10GB/spl (Sample QC + Nextera DNA XT (META) Library and NovaSeqX150PE 10 Gb/sample.
Measured: From enrollment to the end of treatment at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start20 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193927
- Sponsor's protocol ID
- AB-MASLD-25
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No