Impact assessment of potassium competitive acid blocker on the gut microbiota of Anginal patients
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008181
- Lead Sponsor
- Kangwon National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 40
1. A person who is 19 years of age or older as of the date of obtaining written consent
2. Percutaneous coronary intervention (PCI) among patients who were diagnosed with angina and received percutaneous coronary intervention (PCI)
Those who agreed to participate in the study within 1 week of receiving
3. Patients who need double antiplatelet therapy (DAPT) for more than 6 months after percutaneous coronary intervention (PCI)
4. A person who voluntarily decided to participate and gave written consent to the consent form for clinical trial subjects
5. A person who agrees to use a medically valid method of contraception (including conditions where pregnancy is medically impossible) during the clinical trial period
- Women who are medically unable to conceive can participate in this clinical trial: menopause (more than 24 months of menstruation)
cervical), hysterectomy, salpingectomy, bilateral oophorectomy, etc.
- Medically valid methods of contraception: intrauterine devices (loop, Mirena), physical barrier methods (male condom, female condom (Femidom)), subcutaneous contraception (Implanon, etc.), long-acting contraceptive injections or salpingectomy and ligation, vasectomy, etc. (only Oral contraceptives cannot be used during this clinical trial, and it is recommended to use double contraception to prevent pregnancy while participating in this trial.)
1. Those who cannot complete the questionnaire by themselves
2. Those who have a history of hypersensitivity to proton pump inhibitors and potassium-competitive acid blocker components or benzimidazoles
3. Those who have taken proton pump inhibitor (PPI), H2RA, or P-CAB drugs within 4 weeks of Visit 1 (screening start date)
4. Those who have taken antibiotics, prebiotics, probiotics, or synbiotics within 4 weeks from Visit 1 (screening start date)
5. Those with a history of malignant tumor within the last 5 years based on Visit 1 (screening start date)
Those who have been judged for complete remission (CR, pCR) of the tumor and have passed more than 5 years without recurrence from the date of judgment, and the tumor is completely removed through endoscopic gastric mucosal resection (mucosal resection (EMR), submucosal dissection (ESD)) In cases where the disease has occurred, those who have passed more than 3 years without recurrence can be included.
6. Those who have symptoms such as dysphagia, severe dysphagia, bleeding, weight loss, anemia, and bloody stools (except for hemorrhoids), which are warning symptoms” that may presume malignant diseases of the gastrointestinal tract.
7. Patients taking HIV protease inhibitors (atazanavir, nelfinavir) and rilpivirine-containing products
8. Patients with a history of myocardial infarction within 3 months from Visit 1 (screening start date), moderate conduction field
Acute (arrhythmia, cardiac block, angular block, 3rd degree atrioventricular block) patients, patients with acute delirium, patients with paralytic ileus
9. Those who showed the following abnormal values in blood chemistry tests within 4 weeks from Visit 1 (screening start date)
- BUN, Creatinine > 2 times the organ upper limit of normal
- AST, ALT, ALP, total bilirubin > 2 times the upper limit of normal
10. Those with clinically significant disorders in the liver, kidneys, cardiovascular system, respiratory system, endocrine system, and central nervous system
11. Pregnant and lactating women or those who intend to become pregnant
12. Those who participated in other clinical trials within 12 weeks of Visit 1 (screening start date)
- However, you have participated in or are participating in a non-interventional study (observational study, questionnaire study, etc.
Human clinical trial subjects can participate in this trial.
- In addition, in order to participate in other clinical trials, after writing the consent form, administration of clinical trial drugs and screening without treatment
Those who are eliminated from the leaning can participate in this test.
13. Patients with a history of alcohol abuse
14. Persons with bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, and other psychiatric disorders
Those who are presumed to have difficulty in collecting Feces samples
15. Continuous use of corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and anticoagulants during the study period.
patients who need to take
16. Patients with contraindications to the use of antithrombotic agents
17. A person who has not obtained the informed consent of the subject and guardian
18. In addition to the above, clinical significance that the investigator judged medically and considered inappropriate for this test
person with opinions
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in Gut Microbiota Profile
- Secondary Outcome Measures
Name Time Method Whether gastrointestinal bleeding occurs