NSAID-induced small bowel injury
Conditions
Interventions
Subjects in placebo group are administered celecoxib 200 mg twice daily, rabeprazole 20 mg once daily and placebo 3.2 g twice daily for two weeks.
Subjects in WB21 group are administered celecoxib 200
Sponsors
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka Sanno Hospital
Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of peptic ulcers 2) Subjects treated continuously with NSAIDs, including aspirin 3) Subjects with a history of aspirin-induced asthma 4) Subjects allergic to sulufonamids 5) Subjects treated with corticosteroid, anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc), or probiotics 6) Subjects with gastrointestinal stenosis or severe adhesion 7) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease 8) Pregnant and nursing women 9) Subjects with other disorders who are judged inappropriate for the participation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of small bowel mucosal injuries (hemorrhage, ulcer and mucosal break) under capsule endoscopy after 2 weeks medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The number and incidence of small bowel mucosal injuries in the jejunum and ileum. 2) The incidence of gastroduodenal mucosal injuries. 3) Abdominal symptoms, laboratory data and gut microbiota composition | — |
Countries
Japan
Outcome results
None listed