Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial

NCT07193927 | Recruiting Phase 2

• 1 other identifier: AB-MASLD-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Fatty Liver Disease, Nonalcoholic; Overweight (BMI > 25)

Outcome Measures

Primary Outcomes (1)

• Changes in MASLD from baseline

  Evaluated by CAP (controlled attenuation parameter, dB/m) and FAST score \[determined with FibroScan®\]

  From enrollment to the end of treatment at 6 months.

Secondary Outcomes (28)

• Changes from baseline in Liver Fibrosis (kPa)

  From enrollment to the end of treatment at 6 months.

• Changes form baseline in MASLD related index - FLI

  From enrollment to the end of treatment at 6 months.

• Changes form baseline in MASLD related index - FIB-4

  From enrollment to the end of treatment at 6 months.

• Changes form baseline in MASLD related index - APRI

  From enrollment to the end of treatment at 6 months.

• Changes from baseline in metabolic syndrome score (siMS)

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Dietary Supplement: Lactiplantibacillus plantarum Probiotic Mixture

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo comparator containing maltodextrin

Interventions

Lactiplantibacillus plantarum Probiotic Mixture DIETARY_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.

Probiotic

Placebo comparator containing maltodextrin DIETARY_SUPPLEMENT

Placebo comparator containing maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i. 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).
• 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.

You may not qualify if:

• 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:
• i. 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.
• 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:
• i. Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease).
• ii. 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)

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

Hospital Universitari Dr. Josep Trueta

Girona, Girona, 17190, Spain

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Overweight

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

José Manuel Dr. Fernández-Real, PhD

CONTACT

+34 972940200 - 2656; jmfreal@idibgi.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 26, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2025-09

Locations

ES (1)