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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034820
Receipt No. R000039614
Official scientific title of the study Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Date of disclosure of the study information 2018/11/09
Last modified on 2018/11/08

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Basic information
Official scientific title of the study Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Title of the study (Brief title) Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether patients allergic to hen's egg diagnosed using an oral food challenge test can ingest quail eggs safely
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients who can ingest a quail egg without developing symptoms
Key secondary outcomes Percentage of children who can safely ingest a quail egg depending on the severity of their hen's egg allergy
Quail egg white- and quail egg yolk-specific IgE and skin prick test to quail egg white results in patients allergic to hen's egg
Quail egg white- and quail egg yolk-specific IgE and skin prick test to quail egg white results in patients allergic to hen's egg with a positive quail egg oral food challenge test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 Perform an oral food challenge test with a quail egg within one year of the oral food challenge to hen's egg
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 Positive oral food challenge to hen's egg within one year
Key exclusion criteria Subjects judged inappropriate for the study by the research director
Target sample size 300

Research contact person
Name of lead principal investigator Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email mebisawa@foodallergy.jp

Public contact
Name of contact person Masatoshi Mitomori
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of pediatrics
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email aabbk7k7k7@gmail.com

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2018 Year 11 Month 09 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 09 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

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039614

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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