UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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