UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040730 |
|---|---|
| Receipt number | R000046501 |
| Scientific Title | Oral immunotherapy with low allergenic egg contains cookies in 0-5 year old patients |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/06/12 12:06:13 |
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Basic information
Public title
Oral immunotherapy with low allergenic egg contains cookies in 0-5 year old patients
Acronym
Oral immunotherapy with low allergenic egg contains cookies
Scientific Title
Oral immunotherapy with low allergenic egg contains cookies in 0-5 year old patients
Scientific Title:Acronym
Oral immunotherapy with low allergenic egg contains cookies
Region
| Japan |
Condition
Condition
egg allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of oral immunotherapy from infants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the final dose in the oral boiled egg white challenge test after immunotherapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
egg white containing cookies
Interventions/Control_2
egg yolk containing cookies
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
| 7 | months-old | <= |
Age-upper limit
| 73 | months-old | > |
Gender
Male and Female
Key inclusion criteria
egg allergy
Key exclusion criteria
Allergic to ingredients other than egg
non-IgE mediated allergy
Plan to move within 4 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Takaoka |
Organization
osaka Habikino medical center
Division name
department of pediatrics
Zip code
5838588
Address
3-7-1, Habikino, Habikino city
TEL
0729572121
zvb11075@nifty.com
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Takaoka |
Organization
osaka habikino medical center
Division name
department of pediatrics
Zip code
5838588
Address
3-7-1, Habikino, Habikino city
TEL
0729572121
Homepage URL
zvb11075@nifty.com
Sponsor or person
Institute
osaka habikino medical center
Institute
Department
Personal name
Funding Source
Organization
osaka habikino medical center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
osaka Habikino medical center
Address
3-7-1, Habikino, Habikino city
Tel
0729572121
zvb11075@nifty.com
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
| 2020 | Year | 06 | Month | 12 | 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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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