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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005073
Receipt No. R000006030
Scientific Title Randomized controlled trial to evaluate clinical safety and efficacy of oral immunotherapy with low dose of egg for children with egg allergy
Date of disclosure of the study information 2011/02/13
Last modified on 2015/02/26

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Basic information
Public title Randomized controlled trial to evaluate clinical safety and efficacy of oral immunotherapy with low dose of egg for children with egg allergy
Acronym Small dose oral immunotherapy for liberating children from egg allergy
Scientific Title Randomized controlled trial to evaluate clinical safety and efficacy of oral immunotherapy with low dose of egg for children with egg allergy
Scientific Title:Acronym Small dose oral immunotherapy for liberating children from egg allergy
Region
Japan

Condition
Condition Food hypersensitivity,Food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether small amount of egg oral immunotherapy is more effective to increase threshold dose of egg to evoke adverse reaction than elimination therapy of egg
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The result of double -blind placebo controlled food challenge test of egg after 25-28 weeks intervention
Key secondary outcomes 1)The threshold change of egg allergen dose to provoke immediate reaction before and after this intervention
2)The change of egg specific antibody serum concentration before and after this intervention
3)Incidence of patients who experience allergic reaction due to adverse effect of this intervention
4)Onset number of allergic reaction due to adverse effect of this intervention in each case

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 YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To take small amount of egg powder masked with corn powder once daily for 25-28 weeks
Interventions/Control_2 To take corn powder as placebo once daily for 25-28 weeks
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
3 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients who keep complete elimination of egg from their diet
2)Patients who were confirmed as having egg allergy by double blind placebo controlled food challenge test
3)Egg white-specific IgE-positive patients
4)Patients whose family are cooperative enough to adhere to the protocol of this study
Key exclusion criteria 1)Patients without immediate-type reaction to egg
2)Patients with uncontrolled asthma, atopic dermatitis or urticaria
3)Corn allergy patients
4)Patients who have treatment history or plan with omalizumab
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Ohya
Organization National Center for Child Health and Development
Division name Division of Allergy
Zip code
Address 2-10-1,Okura,Setagaya-ku,Tokyo
TEL 03-3416-0181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Tsumura
Organization National Center for Child Health and Development
Division name Division of Allergy
Zip code
Address 2-10-1,Okura,Setagaya-ku,Tokyo
TEL 03-3416-0181
Homepage URL
Email smile-admin@umin.ac.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 (独)国立成育医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 13 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 Terminated
Date of protocol fixation
2011 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 13 Day
Last modified on
2015 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006030

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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