Actively Recruiting

Phase 4
Age: 19Years - 80Years
All Genders
NCT06784557

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

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Severance hospital, Yonsei University College of Medicine

Seoul, South Korea

Actively Recruiting

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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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