Clinical study on the incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury

Clinical study on the incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of aspirin-induced small bowel injury - Incidence of small bowel injury by low-dose aspirin, and efficacy of misoprostol for the treatment of small bowel injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000663

Enrollment

Registered

2007-03-30

Start date

2007-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small bowel injury

Interventions

Misoprostol (800 microgram/day) for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic users of low-dose aspirin with a peptic ulcer who receive therapy with a proton pump inhibitor

Exclusion criteria

Exclusion criteria: 1. Dysphagia. 2. Pregnant, possibly pregnant, or lactating women. 3. With intestinal stricture or intestinal fistula, diagnosed by diagnostic image or past clinical inspection. 4. Using cardiac pacemaker or other self-contained medical electronics. 5. The subject of any other clinical test/trial which will affect the results this study. 6. Can not comply with the study requirements or cannot follow instructions for the device. 7. Extensive esophageal hiatal hernia. 8. Life-threatening disorder. 9. Abdominal radiotherapy in past. 10. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred. 11. Allergic or idiosyncratic to the drug. 12. Inadequate to entry judged by investigators.

Design outcomes

Primary

Measure	Time frame
Capsule endoscopic findings (number of ulcers/erosions and red spots)	—

Secondary

Measure	Time frame
Symptom assessment (anemia, melena, diarrhea, abdominal pain)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026