Effect of Ezetimibe on Gut Microbiota

Launched by YONSEI UNIVERSITY · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ezetimibe on gut bacteria in people with a condition known as atherosclerotic cardiovascular disease, which is related to heart health and cholesterol levels. Ezetimibe is primarily used to lower cholesterol by reducing how much cholesterol is absorbed from food in the intestines. Researchers are interested in understanding how this medication might also affect the bacteria in our gut, as these microorganisms play a role in cholesterol metabolism and overall heart health.

To participate in this trial, individuals need to be between 19 and 80 years old and have been diagnosed with coronary artery disease or have specific cholesterol levels that require treatment. Participants will be asked to give their consent to join the study. Those with certain health issues, such as active liver disease, certain allergies, or recent surgeries, may not be eligible. If you join the study, you can expect to undergo assessments to see how ezetimibe affects your gut bacteria and cholesterol levels, contributing to our understanding of how this medication works and its potential benefits for heart health.

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Eligibility criteria

• 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.