A double-blind, randomized, placebo controlled trial of misoprostol for healing of small bowel ulcers in aspirin users with small bowel bleeding

INTERVENTION: misoprostol 800 micro g/day placebo CONDITION: small bowel ulcers in aspirin users with small bowel bleeding PRIMARY OUTCOME: Complete healing of small bowel ulcers (scores 3 or 4) in 8 weeks. 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