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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035743
Receipt No. R000040584
Scientific Title A study on critical factor in children with food allergy
Date of disclosure of the study information 2019/02/01
Last modified on 2019/02/01

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Basic information
Public title A study on critical factor in children with food allergy
Acronym A study on critical factor in children with food allergy
Scientific Title A study on critical factor in children with food allergy
Scientific Title:Acronym A study on critical factor in children with food allergy
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We investigate what factors are involved in immune tolerance in children with food allergy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes How the immune response changes in vivo with immune tolerance
Key secondary outcomes What kind of immunologic mechanism can cause allergic symptoms?
What factors influence the tolerance acquisition delay?

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

Not applicable
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Patients who visited the outpatient, diagnosed with food allergy by medical history or ingestion of oral food challenge
Key exclusion criteria Patients diagnosed with immunodeficiency or chromosomal abnormalities
Patients who do not have allergy symptoms only by sensitization
Patient who the research director judged unsuitable as a subject
Target sample size 500

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yosuke Baba
Organization Juntendo University Shizuoka Hospital
Division name Department of Pediatrics
Zip code
Address Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL 055-948-3111
Email youbaba@juntnedo.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yosuke Baba
Organization Juntendo University Shizuoka Hospital
Division name Department of Pediatrics
Zip code
Address Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL 055-948-3111
Homepage URL
Email youbaba@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization MEXT (Ministry of Education, Culture, Sports, Science and Technology)-Supported Program for the Strategic Research Foundation at Private Universities Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
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 順天堂大学医学部附属静岡病院(静岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2019 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 A prospective non-interventional observational study

Management information
Registered date
2019 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040584

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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