The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial.
Khadijeh Abhari, Saeede Saadati, Zahra Yari...
https://pubmed.ncbi.nlm.nih.gov/32859329Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07400367
Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Led by Fu Jen Catholic University Hospital · Updated on 2026-04-06
80
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a newly defined condition, formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It involves fatty liver confirmed by imaging or biopsy along with one or more cardiometabolic risk factors such as high blood sugar, abnormal lipids, high blood pressure, or obesity. MASLD is the most common chronic liver disease worldwide, affecting about 30-40% of people. There is currently no approved medicine for MASLD, and lifestyle changes remain the main treatment. The study explores the link between gut microbiota imbalance and MASLD, considering modulation of gut bacteria as a potential therapy. This clinical trial evaluates the effects of a multi-strain probiotic supplement combined with lifestyle modification in adults with MASLD. Participants are randomly assigned to receive either the probiotic product containing specific Lactobacillus and Bifidobacterium strains or a placebo, both alongside standard lifestyle advice from a gastroenterologist. The treatment lasts for 12 weeks, during which the impact on liver fibrosis, fat accumulation, cardiometabolic risk factors, inflammation, and gut microbiota composition is studied. Participants will attend visits over 12 weeks to monitor changes using liver shear wave elastography and ultrasound, blood tests for liver enzymes, lipids, glucose, inflammatory markers, and insulin resistance measures. Researchers will also track body weight, waist circumference, and blood pressure. The study carefully monitors safety and collects data on various blood parameters to assess the probiotic's effect as an adjunct therapy. Total participation duration covers the treatment period and assessments through week 12.
CONDITIONS
Brief Title
Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- ALT level 60 U/L or higher
- Liver steatosis confirmed by ultrasound
- Presence of at least one cardiometabolic risk factor such as:
- BMI 25 kg/m2 or above (23 for Asian individuals)
- Waist circumference over 94 cm for males or 80 cm for females
- Fasting blood glucose 100 mg/dL or higher
- HbA1c 5.7% or higher
- Currently receiving treatment for diabetes
- Currently receiving treatment for hypertension
- Average home blood pressure 130/85 mmHg or higher
- Triglycerides 150 mg/dL or higher
- HDL cholesterol 40 mg/dL or lower
- Currently receiving treatment for dyslipidemia
You will not qualify if you...
- Positive for hepatitis B surface antigen (HBsAg)
- Positive for hepatitis C antibody (Anti-HCV)
- Diagnosis of cirrhosis
- Excessive alcohol intake (more than 210g per week for males; more than 140g per week for females)
- Possible autoimmune hepatitis (positive ANA, AMA, or ASMA tests)
- Possible drug-induced hepatitis
- Current use of drugs that may cause liver steatosis, including glucocorticoids, amiodarone, tamoxifen, methotrexate, valproate, tetracycline, or chemotherapy agents
- Use of immune modulators or biologic therapies
- Use of antibiotics within the past month
- Receiving any cancer treatment
- Diagnosis of a "Catastrophic Illness" as defined by Taiwan's Health Administration
- Estimated glomerular filtration rate (eGFR) below 60
- Pregnancy
- Currently enrolled in another dietary or pharmacological clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take the probiotic or placebo daily while following lifestyle modification education provided by a gastroenterologist.
Regular visits as instructed by the study team for monitoring and assessments
Trial Site Locations
Total: 2 locations
1
Fu Jen Catholic University Hospital
New Taipei City, Taiwan
Not Yet Recruiting
2
Fu Jen Catholic University Hospital
New Taipei City, Taiwan
Actively Recruiting
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Research Team
K
Kuan Wei Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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