NCT07193927
Not yet recruiting
Phase 2
Investigation of the Efficacy of a Probiotic Mixture in Subjects With Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- AB Biotics, SA
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in MASLD from baseline
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged from 18 to 75 years old
- •BMI 25 - 38kg/m2
- •Diagnosed with MASLD and CAP value \> 268 dB/m evaluated by FibroScan®
- •High ALT levels (\>40 U/L in males and \>30 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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Changes in MASLD from baseline
Time Frame: From enrollment to the end of treatment at 6 months.
Evaluated by CAP (controlled attenuation parameter, dB/m) and FAST score \[determined with FibroScan®\]
Secondary Outcomes
- 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.)
- Changes from baseline in weight (kg)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in height (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in Body Mass Index (BMI)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in waist circumference (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in hip circumference (cm)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in waist/hip ratio(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in systolic and diastolic blood pressure.(From entollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of blood-based cell profile.(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum liver enzyme concentrations(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis insulin resistance-related variables(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of cholesterol and fatty acid concentrations:(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of high-sensitivity C-reactive protein (hsCRP) concentration.(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of albumin concentration(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of total bilirubin (TBIL)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of kidney function biomarkers(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of thyroid hormones(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of iron binding capacity(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of electrolytes(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of estimated glomerular filtration rate(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in serum analysis of nutritional and metabolic biomarkers(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)(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in gut microbiota diversity(From enrollment to the end of treatment at 6 months.)
- Changes from baseline in gut microbiota relative abundance(From enrollment to the end of treatment at 6 months.)
Investigators
Study Sites (1)
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