Effect of Ezetimibe on Gut Microbiota

NCT06784557 | Recruiting Phase 4

• 1 other identifier: 4-2023-0161
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease With Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Changes in Gut Microbiota After 12 Weeks of Treatment

  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).

  12 weeks

Secondary Outcomes (1)

• Changes in Blood Lipid Levels and Inflammatory Biomarker Levels After 12 Weeks of Treatment

  12 weeks

Study Arms (2)

Atorvastatin 40mg

ACTIVE COMPARATOR

Drug: Atorvastatin 40mg

Atorvastatin 20mg+Ezetimibe 10mg

EXPERIMENTAL

Drug: Atorvastatin 20mg+Ezetimibe 10mg

Interventions

Atorvastatin 40mg DRUG

High intensity HMG-CoA reductase inhibitor

Atorvastatin 40mg

Atorvastatin 20mg+Ezetimibe 10mg DRUG

Moderate intensity HMG-CoA reductase inhibitor plus NPC1L1 antagonist

Atorvastatin 20mg+Ezetimibe 10mg

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Atorvastatin; Ezetimibe

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Central Study Contacts

jong won ha, MD,PhD

CONTACT

82-2-2228-8460; jwha@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 20, 2025
• Study Start: February 28, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

KR (1)