UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026979
Receipt No. R000022170
Scientific Title Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Date of disclosure of the study information 2017/04/13
Last modified on 2018/08/12

* 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 Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Acronym Effects of environmental and genetic factors for the development of allergic diseases in general population
Scientific Title Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Scientific Title:Acronym Effects of environmental and genetic factors for the development of allergic diseases in general population
Region
Japan

Condition
Condition Allergic diseases
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal effects of feto-maternal or infant-maternal interactions among prenatal environmental factors, such as diet, infections and earth conditions, and genetic factors on the development of allergic diseases in a general population by using epidemiological methods.
Basic objectives2 Others
Basic objectives -Others To apply the results from the studies to strategy for prevention and treatment of allergic diseases.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes development of allergic diseases
Key secondary outcomes Timing of development of allergic diseases
Cure or tolerance of allergic diseases

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
0 months-old <=
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria Kochi Baby Examination has been held annually in spring since the end of the 2nd World War, and is a large baby health medical examination for around 2500 newborn babies in a general population in Kochi, Japan.
The Kochi Baby Examination has been supposed by the Kochi Shinbun-Broadcasting in Kochi, Japan.

Objectives:
* Parents-baby pairs in a general population who participated to the Kochi Baby Examination.
* Parents-baby pairs with written informed consent.
Key exclusion criteria Parents-baby pairs without written informed consent.
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miwa Shinohara
Organization Ehime University Hospital
Division name Department of Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL 089-960-5320
Email shinohara.miwa.vv@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Shinohara
Organization Ehime University Hospital
Division name Department of Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL 089-960-5320
Homepage URL
Email shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute Department of Pediatrics, Ehime University Hospital
Institute
Department

Funding Source
Organization Ehime University Hospital
Department of Pediatrics
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Allergy and Immunology, National Center for Child Health and Development
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 愛媛大学医学部附属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Our results suggest the presence of possible epigenetic mechanisms regulating the onset of AR in humans presumably through increased organ-specific hypersensitivity.
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 Main results already published
Date of protocol fixation
1999 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
1999 Year 01 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 Allergol Int. 2007 Dec;56(4):411-7. Epub 2007 Sep 1.

Symptoms of allergic rhinitis in women during early pregnancy are associated with higher prevalence of allergic rhinitis in their offspring.

Shinohara M1, Wakiguchi H, Saito H, Matsumoto K.

https://www.ncbi.nlm.nih.gov/pubmed/17713362

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2018 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.