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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001268
Receipt No. R000001543
Scientific Title oral desensitization therapy in children with food allergy
Date of disclosure of the study information 2008/12/15
Last modified on 2017/01/30

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Basic information
Public title oral desensitization therapy in children with food allergy
Acronym oral desensitization therapy in children with food allergy
Scientific Title oral desensitization therapy in children with food allergy
Scientific Title:Acronym oral desensitization therapy in children with food allergy
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy and safety of oral desensitization therapy in children with food allergy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes difference of tolerance rate between treatment group and elimination group
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 gradually increased ingestion of egg or milk
Interventions/Control_2 elimination of egg or milk
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
15 years-old >
Gender Male and Female
Key inclusion criteria patients with immediate allergic reaction for egg or milk in double blind placebo control food challenge test
Key exclusion criteria patients with poorly controlled asthma or atopic dermatitis
Target sample size 72

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Center for Child Health and Development
Division name Division of Allergy
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute National Center for Child Health and Development Division of Allergy
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO, LTD
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27914210
Number of participants that the trial has enrolled
Results Eight of the 14 (57%) patients in the OIT group passed 4 g of dry egg powder whereas none of the 16 patients in the EE group did. All 14 patients in the OIT group showed increased threshold for egg powder in the second OFC compared to the baseline. There was no significant change in egg white-specific IgE levels during therapy. After therapy, egg white-specific IgG4 levels increased significantly in the OIT group, but not in the EE group.
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 Completed
Date of protocol fixation
2005 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 25 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001543

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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