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Recruiting Phase 4

Effect of Ezetimibe on Gut Microbiota

NCT06784557 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2024-02-28
Last updated
2025-01-20

Condition(s) studied

Atherosclerotic Cardiovascular Disease With Dyslipidemia

Investigational drug(s) / intervention(s)

Atorvastatin 40mg →Atorvastatin 20mg+Ezetimibe 10mgAll Atorvastatin trials (44) →All Ezetimibe trials (15) →

Atorvastatin 40mg: High intensity HMG-CoA reductase inhibitor

Atorvastatin 20mg+Ezetimibe 10mg: Moderate intensity HMG-CoA reductase inhibitor plus NPC1L1 antagonist

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Age: 19 to 80 years old * Criteria for Diagnosis of Coronary Artery Disease: Patients diagnosed with coronary artery disease through coronary angiography, or Patients who require high-intensity lipid-lowering therapy according to current guidelines: Clinical atherosclerotic cardiovascular disease, LDL cholesterol ≥ 190 mg/dL, LDL 70-189 mg/dL in diabetic patients, 10-year calculated atherosclerotic cardiovascular disease risk ≥ 7.5% \- Voluntary Consent: Individuals who have voluntarily agreed to participate in the study and signed the consent form. Exclusion Criteria: * Patients with active liver disease or liver disease with AST/ALT levels elevated more than twice the upper limit of normal. * Individuals with allergies or hypersensitivity to HMG-CoA reductase inhibitors or ezetimibe. * Individuals with a history of adverse reactions to HMG-CoA reductase inhibitors or ezetimibe. * Pregnant, breastfeeding, or women of childbearing potential. * Organ transplant recipients or individuals scheduled for organ transplantation. * Patients with active malignant tumors. * Patients with inflammatory bowel disease. * Patients with wasting diseases, autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), or connective tissue diseases (e.g., systemic sclerosis, polymyositis, and dermatomyositis). * Patients with a history of taking antibiotics, probiotics, or ezetimibe within 3 months prior to study screening. * Patients who have undergone gastrointestinal surgery within the past year. * Patients who do not understand the study content or are unable to provide consent.

Primary outcome measure(s)

  • Changes in Gut Microbiota After 12 Weeks of Treatment — 12 weeks
    Gut Microbiota difference after intervention Stool samples are analyzed using 16S rRNA sequencing. Statistical tests compare microbiota differences: Between groups at baseline (T-test or Mann-Whitney test). Pre- and post-treatment within groups (Paired t-test or Wilcoxon test). Intergroup changes over time (ANOVA test).

Trial sites (1)

FacilityCityRegionStatus
Severance hospital, Yonsei University College of Medicine Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06784557 on ClinicalTrials.gov ↗ ← All trials in South Korea