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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027332
Receipt No. R000030365
Scientific Title Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Date of disclosure of the study information 2017/05/16
Last modified on 2017/05/13

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Basic information
Public title Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Acronym Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Scientific Title Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Scientific Title:Acronym Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Region
Japan

Condition
Condition Hen's egg allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate in a multicenter placebo controlled randomized trial whether introducing very small amounts of heated hen's egg in severe egg allergic children less than 2 years old induces desensitization and sustained unresponsiveness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of patients desensitized to 1/8 of heated hen's egg after 6 months, confirmed with a double-blind, placebo-controlled food challenge (DBPCFC)
Key secondary outcomes Frequency and severity of adverse events at home during the trial.
Changes in egg white and ovomucoid specific IgE, IgG, IgG4 measured before trial and after 6 and 12 months of the trial.
Changes in skin prick test results tested before trial and after 6 and 12 months of the trial.
Sustained unresponsiveness to 1/2 of heated hen's egg within 1.5 years of initiation of the trial.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intake of heated hen's egg powder for 6 months. The dose of intake for the initial 1 month is 0.2g of heated hen' egg powder (50mg of egg protein). After 1 month, the intake amount is gradually increased towards the target dose of 1g of heated hen's egg powder (250mg of egg protein).
Interventions/Control_2 Daily intake of placebo powder for 6 months. The dose of intake for the initial 1 month is 0.2g of placebo powder. After 1 month, the intake amount is gradually increased towards the target dose of 1g of placebo 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
10 months-old <=
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria Positive oral food challenge to 1/32 of heated hen's egg (250mg of egg protein) within 3 months of initiation of the trial.
Capable of consuming 1/160 of heated hen's egg (50mg of egg protein) without allergic symptoms.
Key exclusion criteria Severe allergic symptoms or symptoms requiring the use of adrenaline during the oral food challenge to 1/32 of heated hen's egg (250mg of egg protein).
Regular intake of hen's egg before initiation of trial.
Severe (uncontrolled) atopic dermatitis before intiation of trial.
Two or more hospitalizations due to wheezing episodes in the previous 6 months before initiation of trial
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email m-ebisawa@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Nishino
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japmi-ku Sakuradai 18-1 Sagamihara, Japan
TEL 042-742-8311
Homepage URL
Email precastudy@gmail.com

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 国立病院機構相模原病院(神奈川)、国立病院機構三重病院(三重)、あいち小児保健医療総合センター(愛知)、千葉大学大学院医学研究院(千葉)、福井大学医学部付属病院(福井)、東京慈恵会医科大学付属病院(東京)、東京医科大学病院(東京)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 16 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 13 Day
Last modified on
2017 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030365

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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