Small bowel mucosal injury
Conditions
Interventions
Enteric-coated aspirin 100 mg/day for 14 days - (washout period of at least 4 weeks) - no drug for 14 days
No drug for 14 days - (washout period of at least 4 weeks) - enteric-coated aspirin 100 mg/d
Sponsors
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a. Healthy male subjects who have a normal physical examination and laboratory results b. Obtaining informed consent
Exclusion criteria
Exclusion criteria: a. Subjects taken NSAID or aspirin within the last 3 months b. Allergic or idiosyncratic to the drug c. Useage of antiulcer medication (H2RA, PPI or misoprostol) d. Chronic alcohol consumption e. A history of abdominal surgery f. Serious central nervous system g. Psychiatric diseases h. Cardiovascular diseases i. Respiratory diseases j. Gastrointestinal diseases k. The subject of any other clinical test/trial which will affect the results this study l. Can not comply with the study requirements or cannot follow instructions for the device m. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred o. Inadequate to entry judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of capsule endoscopic findings (red spots, loss of villi, mucosal breaks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom assessment (abdominal pain, diarrhea, melena) | — |
Countries
Japan
Outcome results
None listed