UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041835 |
|---|---|
| Receipt number | R000047474 |
| Scientific Title | Novel diagnostics for allergy in infants with high risk of developing food allergy: Qualitative and quantitative measurement of specific IgE |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2023/09/21 11:58:30 |
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Basic information
Public title
Prediction of food allergy development
Acronym
Prediction of food allergy
Scientific Title
Novel diagnostics for allergy in infants with high risk of developing food allergy: Qualitative and quantitative measurement of specific IgE
Scientific Title:Acronym
Prediction of food allergy by qualitative evaluation of specific IgE
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing whether IgE quality and quantity and class switch patterns predict the development of food allergy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between food allergy development and IgE avidity
Key secondary outcomes
Relationship between food allergy development and immunoglobulin class switch
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
| 3 | months-old | <= |
Age-upper limit
| 8 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1) diagnosis of atopic dermatitis
2) less than 5 months old before start of weaning food
3) less than 8 months old and suspected egg or milk allergy
4) less than 8 months old and higher than 7 at EASI score
Key exclusion criteria
1) congenital immune deficiency
2) use of suppressants
3) any severe underlying disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Fujisawa |
Organization
Mie National Hospital
Division name
Department of Clinical Research
Zip code
514-0125
Address
357 Ozato-Kubota, Tsu, Mie, Japan
TEL
059-232-2531
eosinophilosophy@gmail.com
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Takase |
Organization
Mie National Hospital
Division name
Department of Pediatrics
Zip code
514-0125
Address
357 Ozato-Kubota, Tsu, Mie, Japan
TEL
059-232-2531
Homepage URL
takatak817@gmail.com
Sponsor or person
Institute
Department of Clinical Research, Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie National Hospital
Address
357 Ozato-Kubota, Tsu, Mie, Japan
Tel
059-232-2531
mieclinicalresearch@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
国立病院機構三重病院（三重県）、徳島大学先端酵素学研究所（徳島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 18 | 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
101
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Infants under 5 months of age with a diagnosis of atopic dermatitis before weaning are enrolled in the study. Blood samplings are performed at 3-5 months of age, 6-8 months of age, 9-11 months of age, and 12-14 months of age. Severity of atopic dermatitis and weaning diet history are also recorded at the same time points. At 12-14 months,oral food challenge tests of eggs and milk are performed to confirm presence/absence of food allergy. IgE antibody quality and quantity and class switch patterns are analysed to test whether the biomarkers predict food allergy development.
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047474
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/01/14 | 20201211臨床研究計画書ハイリスク乳児＿エントリー変更 .docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
