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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009364
Receipt No. 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

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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
Email 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
Email cancer@gol.com

Sponsor
Institute Graduate School of Medical Science, Kyoto
Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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


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