drugset / Trial / NCT03962283

Rifaximin and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users

NCT03962283

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Background: Investigators have previously shown that misoprostol can heal small bowel ulcers in aspirin users with small bowel bleeding. However, the rate of small-bowel mucosal healing was low with use of misoprostol alone. There is evidence to suggest that bacteria contribute to the development aspirin-induced ulcers and antibiotics may be useful in its treatment. Rifaximin, a non-absorbed oral antibiotic that target the gastrointestinal tract have been shown to be safe and effective in a few other gastrointestinal conditions. Small bowel capsule is the most sensitive and non-invasive way to investigate the small bowel. It plays an important role in obscure GIB investigations. Aims: The aim of this randomized study is to test the hypothesis that misoprostol combined with rifaximin is superior to misoprostol alone for healing of small bowel ulcers in aspirin users complicated by small bowel bleeding. Study design: 8-week double-blind randomized trial

Timeline

Start
2019-08-02
Primary completion
2022-06-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rifaximin Other / unclassified 200 ug Oral