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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034608
Receipt No. R000039452
Scientific Title The assessment for the predictive factor for the result of the oral food challenge test
Date of disclosure of the study information 2018/10/23
Last modified on 2018/10/23

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Basic information
Public title The assessment for the predictive factor for the result of the oral food challenge test
Acronym The prediction for the result of the oral food challenge test
Scientific Title The assessment for the predictive factor for the result of the oral food challenge test
Scientific Title:Acronym The prediction for the result of the oral food challenge test
Region
Japan

Condition
Condition Food Allergy
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the laboratory data and patient background which affects the results of the oral food challenge test
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The factors related to the positive or negative for the oral food challenge test
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who underwent the oral food challenge test
Key exclusion criteria The patients who could not perform the oral food challenge test properly due to the anxiety or will of patient or family.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Kawamoto
Organization Gifu University Hospital
Division name Department of Pediatrics
Zip code
Address 1-1 Yanagido Gifu, Gifu Pref.
TEL +81-58-230-6386
Email noriok-gif@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Kawamoto
Organization Gifu University Hospital
Division name Department of Pediatrics
Zip code
Address 1-1 Yanagido Gifu, Gifu Pref.
TEL +81-58-230-6386
Homepage URL
Email noriok-gif@umin.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Gifu University
Organization
Division
Category of Funding Organization Other
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
2018 Year 10 Month 23 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 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 The result of an oral food challenge test, threshold dose, symptom of oral food challenge test, food, age, sex, family history, past history, other allergic histories, type of feeding during infancy, perinatal history, prick test, blood test (total and specific IgE, WBC, Neutrophils, Lymphocytes, Eosinophils, Monocytes, Basophils, TARC, LDH, HRT)

Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2018 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039452

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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