Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial
Not Applicable
- Conditions
- SAID-induced small bowel injury
- Registration Number
- JPRN-UMIN000026358
- Lead Sponsor
- Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Healthy volunteers obtained written informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence rate of small bowel mucosal injuries (hemorrhage, ulcer and mucosal break) under capsule endoscopy after 2 weeks medication.
- Secondary Outcome Measures
Name Time Method 1) The number and incidence of small bowel mucosal injuries in the jejunum and ileum.<br>2) The incidence of gastroduodenal mucosal injuries.<br>3) Abdominal symptoms, laboratory data and gut microbiota composition