UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009364 |
|---|---|
| Receipt number | R000011004 |
| Scientific Title | Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis |
| Date of disclosure of the study information | 2012/11/24 |
| Last modified on | 2016/09/29 10:33:49 |
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Basic information
Public title
Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis
Acronym
long-term administration of FBRA in patients with UC
Scientific Title
Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis
Scientific Title:Acronym
long-term administration of FBRA in patients with UC
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness and safety of long-term administration of fermented brown rice by Aspergillus oryzae (FBRA) in patients with ulcerative colitis (UC) in a single-arm study, and to determine the feasibility of performing a randomized study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with UC who are to be comprehensively diagnosed based on clinical, endoscopic and histological findings.
Key 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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ishikawa MD, PhD |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer
Zip code
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishikawa MD, PhD |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto
Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Science, Kyoto
Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
石川消化器内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 09 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/09/29 | 160825UMIN登録_FBRA長期投与試験 160916追加.xlsx |
