UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005073 |
|---|---|
| Receipt number | 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 17:11:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
smile-admin@umin.ac.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.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 |
