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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035708
Receipt No. R000040661
Official scientific title of the study examination of effectiveness and safety of oral immunization for food allergy patients
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

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Basic information
Official scientific title of the study examination of effectiveness and safety of oral immunization for food allergy patients
Title of the study (Brief title) oral immunization for food allergy
Region
Japan

Condition
Condition food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 determine safety and effectiveness of oral immunotherapy for food allergy patient
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Intake of any dose of allergen without symptom
Key secondary outcomes Intake of small dose of allergen without symptom

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 taking of allergen food
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
6 months-old <=
Age-upper limit
240 months-old >=
Gender Male and Female
Key inclusion criteria complete elimination diet with history of anaphylaxis
Key exclusion criteria patient who have been produced anaphylaxis by a trace of allergen
Target sample size 300

Research contact person
Name of lead principal investigator Yasuhiro Takeshima
Organization Hyogo College Of Medicine
Division name pediatric department
Address Mukogawa 1-1,Nishinomiya city,Hyogo pref. Japan
TEL 0798-45-6352
Email ped-ped@hyo-med.ac.jp

Public contact
Name of contact person Yasuhiko Tanaka
Organization Hyogo College Of Medicine
Division name pediatric department
Address Mukogawa 1-1,Nishinomiya city,Hyogo pref. Japan
TEL 0798-45-6352
Homepage URL
Email tana-ped@hyo-med.ac.jp

Sponsor
Institute Hyogo College Of Medicine
Institute
Department

Funding Source
Organization Hyogo College Of Medicine
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
2019 Year 02 Month 08 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 02 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

Management information
Registered date
2019 Year 01 Month 29 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040661

Research Plan
Registered date File name
2019/01/29 経口免疫療法・実施計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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