small bowel ulcers in aspirin users with small bowel bleeding
Conditions
Interventions
misoprostol 800 micro g/day
placebo
Sponsors
Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. suspected small bowel overt bleeding – melena or hematochezia with normal upper endoscopy and colonoscopy, 2. suspected small bowel occult blood loss – defined as a significant decrease in hemoglobin (> 2g/dL), with normal upper endoscopy and colonoscopy, confirmed iron deficiency anemia, and absence of other identifiable causes for hemoglobin decrease (e.g. fluid overload, progressive renal failure, malnutrition, or other hematological disorders such as hemolysis or malignancies) 3. continuous use of ASA for the duration of the trial 4. age ≥ 20 5. written informed consent obtained
Exclusion criteria
Exclusion criteria: 1. increased risk of capsule retention (e.g. gastric outlet obstruction, bypass surgery, Crohn's disease or suspected small bowel stricture) 2. abnormal findings on upper endoscopy (e.g. esophageal varices, grade C or D erosive esophagitis, vascular malformations, ulcer more than five erosions, neoplasms) or colonoscopy (e.g. cancer, polyps >1 cm, inflammatory bowel disease, vascular malformations, bleeding hemorrhoids or diverticular disease) 3. unable to swallow the video capsule 4. terminal illness 5. concomitant use of NSAIDs, sucralfate, rebamepide, anticoagulants, corticosteroids (prednisolone >7.5 mg daily or equivalent), and iron supplement 6. pregnancy or women of child-bearing age without regular use of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing of small bowel ulcers (scores 3 or 4) in 8 weeks. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactTetsuya Tanigawa
Osaka City University Graduate School of Medicine Department of Gastroenterology
Outcome results
None listed