ulcerative colitis
Conditions
Interventions
Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years.
Sponsors
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with UC who are to be comprehensively diagnosed based on clinical, endoscopic and histological findings.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHideki Ishikawa MD, PhD
Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Molecular-Targeting Cancer Prevention
Outcome results
None listed