UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049666 |
|---|---|
| Receipt number | R000056534 |
| Scientific Title | Significance of low-affinity specific serum IgE for food allergy |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/11/29 16:59:54 |
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Basic information
Public title
Significance of low-affinity specific serum IgE for food allergy
Acronym
Significance of low-affinity specific serum IgE for food allergy
Scientific Title
Significance of low-affinity specific serum IgE for food allergy
Scientific Title:Acronym
Significance of low-affinity specific serum IgE for food allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate role of low-affinity specific serum IgE in prediction of onset, diagnosis and monitering of immunotherapy for food allergy
Basic objectives2
Others
Basic objectives -Others
To elucidate role of specific serum IgG4 in prediction of onset, diagnosis and monitering of immunotherapy for food allergy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction of allergic symptoms during oral food challenge and oral immunotherapy to measure low-affinity specific serum IgE antibody
Key secondary outcomes
Prediction of allergic symptoms during oral food challenge and oral immunotherapy to measure specific serum IgG4 antibody
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 | months-old | < |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children who was suspected or diagnosed as food allergy
Key exclusion criteria
Children with uncontrolled asthma or atopic dermatitis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shoihciro |
| Middle name | |
| Last name | Taniuchi |
Organization
Takatsuki Genreal Hospital
Division name
Pediatrics
Zip code
569-1192
Address
1-3-13, Kosobe-cho, Takatsuki city
TEL
0726813801
taniuchishoichiro@gmail.com
Public contact
Name of contact person
| 1st name | Shoihciro |
| Middle name | |
| Last name | Taniuchi |
Organization
Takatsuki General Hospital
Division name
Pediatrics
Zip code
569-1192
Address
1-3-13, Kosobe-cho, Takatsuki city
TEL
0726813801
Homepage URL
taniuchishoichiro@gmail.com
Sponsor or person
Institute
Takatsuki General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takatsuki General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Enzyme Chemistry, Institute for
Enzyme Research, Tokuchima Univesity, Tokushima
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takatsuki General Hospital
Address
1-3-13, Kosobe-cho, Takatsuki-city
Tel
0726813801
taniuchishoichiro@gmail.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
| 2023 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluated whether low-affinity specific IgE to ovomucoid may predict allergic symptoms during oral immunotherapy and oral food challenge in children with hen's egg allergy
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056534
| 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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| Registered date | File name |
