UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014931 |
|---|---|
| Receipt number | R000017374 |
| Scientific Title | slow specific oral torerance induction used by low allegen cookies for egg allergy |
| Date of disclosure of the study information | 2014/08/23 |
| Last modified on | 2020/06/12 12:11:25 |
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Basic information
Public title
slow specific oral torerance induction used by low allegen cookies for egg allergy
Acronym
slow specific oral torerance induction used by low allegen cookies
Scientific Title
slow specific oral torerance induction used by low allegen cookies for egg allergy
Scientific Title:Acronym
slow specific oral torerance induction used by low allegen cookies
Region
| Japan |
Condition
Condition
egg allergy patient
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effcacy of slow specific oral tolerance inductinon used by low allergen cookies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of starting to eat more than 0.5g egg white without any symptoms after 4 months oral tolerance inductions
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
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
oral immunnotherapy by low allergen cookies
Interventions/Control_2
oral immunnotherapy by plasebo 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
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients unable to eat more than 0.5g egg white by the positive result of oral egg white challenge test
Key exclusion criteria
patients able to eat more than 0.5g egg white by the result of oral egg white challenge test
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yuri takaoka |
Organization
osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic diseases
Division name
department of pediatrics
Zip code
Address
3-7-1 habikino habikino city osaka583-8588japan
TEL
072-957-2121
takaokayu@ra.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yuri takaoka |
Organization
osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic
Division name
department of pediatrics
Zip code
Address
3-7-1 habikino habikino city osaka583-8588japan
TEL
072-957-2121
Homepage URL
takaokayu@ra.opho.jp
Sponsor or person
Institute
osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic diseases
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 23 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 23 | 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=R000017374
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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