Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000005314
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
-Granulocyte count is not more than 2,000/mm3 -Serious infectious disease -Proctitis -Use of enema, suppository(Mesalazine,sulfasalazine stroids) within last 2 weeks -Introduce or increase the dosage of Mesalazine,sulfasalazine within the last 4 weeks -Introduce or increase the dosage of Steroids (intravenous infusion,oral) within the last 2 weeks -Use of total parental nutrition within last 4 weeks -Introduce or increase the dosage of Cycrosporine,tacrolimus within the last 4 weeks -Introduce or increase the dosage of 6-mercaptopurine, azathioprine within the last 4 weeks -Use of Infliximab with in last 6 weeks -Use of GCAP,LCAP with in last 8 weeks -History of colectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucosal healing rate(Endoscopic Score of Mayo index)
- Secondary Outcome Measures
Name Time Method -Remission rate(Mayo and CAI score) -Efficacy(Mayo and CAI score) -Expression of mRNA level of inflammatory cytokines and regenerating factors in mucosa