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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024018
Receipt No. R000027661
Scientific Title Case Control Study to detect risk factors of pollen allergy for university students
Date of disclosure of the study information 2016/09/30
Last modified on 2017/03/14

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Basic information
Public title Case Control Study to detect risk factors of pollen allergy for university students
Acronym Case Control Study for pollen allergy
Scientific Title Case Control Study to detect risk factors of pollen allergy for university students
Scientific Title:Acronym Case Control Study for pollen allergy
Region
Japan

Condition
Condition Adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We detect pollen allergy student (case) and not pollen allergy student (control), and ask them about their birth place, breast feeding or not, take Lactic acid bacteria or not. Our aim is to evaluate risk factors about incidence of pollen allergy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Breast feeding or not
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
60 years-old >
Gender Male and Female
Key inclusion criteria Students at Keio University School of Medicine
Key exclusion criteria None
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Takebayashi
Organization Keio University
Division name School of Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku
TEL 0353633758
Email ayanotakeuchi@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayano Takeuchi
Organization Keio University
Division name School of Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku
TEL 0353633758
Homepage URL
Email ayanotakeuchi@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Results will not publish because this study carried out within the university classes.

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027661

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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