ong-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis
Phase 2
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000009364
- Lead Sponsor
- Graduate School of Medical Science, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have difficulty in eating or drinking. Patients receiving corticosteroid or immunosuppressive agents (previous use is allowed). Patients with a history of allergy to brown rice. Patients who are determined by their attending physicians to be ineligible to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the percent change in the time to normalization during the 2-year period after participation in the study compared to that during the 2-year period before participation. The time to normalization is defined as the period from the onset of an abnormal C-reactive protein or white blood cell count in the peripheral blood to their normalization.
- Secondary Outcome Measures
Name Time Method The secondary endpoints are the development of adverse events during the study, as well as various immunological parameters, clinical activity index (CAI), biochemical parameters, and endoscopic improvement after participation in the study compared to baseline.