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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000009364 |
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Date of registration:
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24/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis
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Scientific title:
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Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis - long-term administration of FBRA in patients with UC |
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Date of first enrolment:
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2012/11/24 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011004 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideki Ishikawa MD, PhD |
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Address:
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3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
Japan |
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Telephone:
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06-6202-5444 |
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Email:
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cancer@gol.com |
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Affiliation:
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Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Molecular-Targeting Cancer Prevention |
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Name:
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Hideki Ishikawa MD, PhD |
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Address:
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3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
Japan |
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Telephone:
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06-6202-5444 |
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Email:
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cancer@gol.com |
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Affiliation:
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Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Molecular-Targeting Cancer |
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Key inclusion & exclusion criteria
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Inclusion 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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ulcerative colitis
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Intervention(s)
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Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Graduate School of Medical Science, Kyoto Prefectural University of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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