UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018124
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.