Safety and efficacy of topical tacrolimus therapy for refractory pouchitis
Phase 1
- Conditions
- pouchitis
- Registration Number
- JPRN-UMIN000006658
- Lead Sponsor
- Department of lower gastroenterological surgery, Hyogo college of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Concomitant administrations of other immunosuppressive therapies which includes corticosteroids,immunomodurators or biologics and 5-aminosalicylate or other local therapies which includes enemas or suppositories were not allowed.The patients with allergy for tacrolimus wereexcluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of treatment was defined Pouchitis Disease Activity Index score with each parameter which includes clinical symptoms, endoscopic appearance, and histopathological findings. These parameters were assessed at before and after treatment.
- Secondary Outcome Measures
Name Time Method