Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Phase 1
- Conditions
- onspecific multiple ulcers in the small intestine unrelated to NSAID (Chronic enteropathy associated with SLCO2A1: CEAS)
- Registration Number
- JPRN-UMIN000030327
- Lead Sponsor
- Fujita Health University, Department of Gastroenterology
- Brief Summary
1. Lubiprostone should be carefully prescribed especially to patients with small bowel stenosis. 2. The enteroscopic improvement with 12 microgram of lubiprostone was limited in patietns with CEAS. 3. Electron microscopy revealed the increased volume of water between cells by administration of lubiprostone with intact tight junction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
1) Contraindications of enteroscopy 2) Bad conditions such as small bowel obstruction 3) Severe cardiac or pulmonary disease 4) Allergy to lubiprostone or contraindications of lubiprostone 5) Within 1 month of another clinical trial 6) Pregnant or lactating women 7) Man or woman who does not comply with this trial 8) Inappropriate situations judged by attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Enteroscopic improvement after lubiprotone treatment 2) Endocmicroscopic improvement of leaky gut syndrome
- Secondary Outcome Measures
Name Time Method 1)Serum iron, ferritin, total protein, and albumin 2) Urine PGE-MUM/Cr 3) Fecal calprotectin 4) Oter blood test data 5) Symptomatic improvement 6) Pathologic change 7) Bowel movements