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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033346
Receipt No. R000038017
Official scientific title of the study Randomized trial of ingestion method of oral immunotherapy for severe egg allergic patients
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Randomized trial of ingestion method of oral immunotherapy for severe egg allergic patients
Title of the study (Brief title) Randomized trial of ingestion method of oral immunotherapy for severe egg allergic patients
Region
Japan

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

Objectives
Narrative objectives1 To clarify the appropriate method of OIT ("heated egg powder" vs "scrambled egg") for severe egg allergy after achieving desensitization by using heated egg powder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained unresponsiveness to half of whole egg after 12 months
Key secondary outcomes Changes of egg-white and ovomucoid specific IgE, IgG, IgG4
Frequency of adverse reactions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral immunotherapy by using scrambled egg
Interventions/Control_2 Oral immunotherapy by using heated whole egg powder
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who performed oral immunotherapy by using heated whole egg powder for 12 months or more.
Patients who achieved desensitization to one eight of whole egg for 3 months or more.
Patients who failed oral immunotherapy of half of whole egg after 2 weeks avoidance.
Key exclusion criteria Decision of ineligibility by a physician
Target sample size 46

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 s-satou@sagamihara-hosp.gr.jp

Public contact
Name of contact person Ken-ichi Nagakura
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 k-nagakura@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 07 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 07 Month 17 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 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038017

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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