UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018124 |
|---|---|
| Receipt number | R000020985 |
| Scientific Title | Selection of The Target Population to Evaluate the Effect of Functional Foods with Regard to the Amelioration of Pollinosis Caused by Japanese White Birch (Betula platyphylla var. japonica) |
| Date of disclosure of the study information | 2015/06/29 |
| Last modified on | 2017/06/15 14:05:38 |
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Basic information
Public title
Selection of The Target Population to Evaluate the Effect of Functional Foods with Regard to the Amelioration of Pollinosis Caused by Japanese White Birch (Betula platyphylla var. japonica)
Acronym
A Preliminary Research for The Ameliorating Effect for White Birch Pollinosis by A Functional Food
Scientific Title
Selection of The Target Population to Evaluate the Effect of Functional Foods with Regard to the Amelioration of Pollinosis Caused by Japanese White Birch (Betula platyphylla var. japonica)
Scientific Title:Acronym
A Preliminary Research for The Ameliorating Effect for White Birch Pollinosis by A Functional Food
Region
| Japan |
Condition
Condition
Japanese white birch pollinosis
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct the appropriate target population to evaluate the effect of white birch pollinosis by functional foods according to diagnosis of skin allergic reaction, specific IgE antibody level, questionnaires for pollinosis symptoms, etc. as objective data.
Basic objectives2
Others
Basic objectives -Others
Collecting white birch pollinosis cases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Total IgE, White birch-specific IgE,
skin prick test, questionnaires for pollinosis symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who have symptoms of pollinosis in the last 2 years.
2. Subjects who accept allergy tests of white birch pollen (collecting blood and skin prick test).
3. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects with serious cerebrovascular, cardiac, hepatic, renal and / or endocrine and metabolic disorders, or affected with infectious diseases requiring report to the authorities.
2. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries.
3. Subjects who have a serious anemia.
4. Subjects who have a history of serious allergic reactions (anaphylaxis, etc.).
5. Subject who have sinusitis, nasal polyp, hypertrophic rhinitis, more than moderate chronic nasal inflammation, severe nasal septum deviation, etc.
6. Subjects who have bronchial asthma
7. Subject who are under immunotherapy such as allergen- specific desensitization.
8. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
9. Subjects who donated either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
10. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
11. Subjects who participated in other clinical trials within the last one month prior to the clinical trial.
12. Any other medical reasons judged by the doctor in charge.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Yotsuba Milk Products Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 29 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 13 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2015 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020985
