UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Case Control Study to detect risk factors of pollen allergy for university students
Title of the study (Brief title)	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	Toru Takebayashi
Organization	Keio University
Division name	School of Medicine
Address	35 Shinanomachi, Shinjyuku-ku
TEL	0353633758
Email	ayanotakeuchi@keio.jp

Public contact
Name of contact person	Ayano Takeuchi
Organization	Keio University
Division name	School of Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027661