Actively Recruiting
Effect of Ezetimibe on Gut Microbiota
Led by Yonsei University · Updated on 2025-01-20
110
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ezetimibe exerts its primary effects by inhibiting intestinal cholesterol absorption through the NPC1L1 protein. Beyond this, its impact on gut microbiota remains an area of interest. Gut microbiota has been implicated in cholesterol metabolism and CVD pathogenesis through metabolic and non-metabolic pathways. Modulating gut microbiota has been explored as a potential strategy to prevent CVDs. Despite its intestinal mechanism, the influence of ezetimibe on gut microbiota composition has not been thoroughly investigated. Future studies are needed to elucidate its potential interactions with gut microbial communities and their implications for cholesterol metabolism and cardiovascular health.
CONDITIONS
Official Title
Effect of Ezetimibe on Gut Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 80 years old
- Diagnosed with coronary artery disease by coronary angiography, or
- Require high-intensity lipid-lowering therapy based on current guidelines (clinical atherosclerotic cardiovascular disease, LDL cholesterol 65 190 mg/dL, LDL 70-189 mg/dL in diabetic patients, or 10-year ASCVD risk 65 7.5%)
- Voluntarily agree to participate and have signed informed consent
You will not qualify if you...
- Active liver disease or liver disease with AST/ALT levels more than twice the upper limit of normal
- Allergy or hypersensitivity to HMG-CoA reductase inhibitors or ezetimibe
- History of adverse reactions to HMG-CoA reductase inhibitors or ezetimibe
- Pregnant, breastfeeding, or women of childbearing potential
- Organ transplant recipients or scheduled for organ transplantation
- Active malignant tumors
- Inflammatory bowel disease
- Wasting diseases, autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), or connective tissue diseases (e.g., systemic sclerosis, polymyositis, dermatomyositis)
- Use of antibiotics, probiotics, or ezetimibe within 3 months prior to screening
- Gastrointestinal surgery within the past year
- Unable to understand the study or provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance hospital, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
J
jong won ha, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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