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 | 2025/04/18 21:58:16 |
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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
https://mie.hosp.go.jp/common/pdf/opt_23.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=ev2areru/2023/s03704/004&name=0354-035
Number of participants that the trial has enrolled
101
Results
We recruited 101 infants with atopic dermatitis, and 85 were analyzed. Ten tested positive for hen's egg and three for cow's milk in the oral food challenge (OFC). Specific IgE to egg white, ovalbumin, and ovomucoid were higher in the OFC-positive group, while IgG4 tended to be higher in the OFC-negative group. Due to the small number of cow's milk OFC-positive cases, no significant differences were found for cow's milk components.
Results date posted
| 2025 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Infants diagnosed with atopic dermatitis based on the U.K. Working Party's diagnostic criteria who met one of the following conditions were enrolled:
(1) Infants younger than 5 months of age who had not yet started complementary feeding;
(2) Infants younger than 8 months of age with suspected hen's egg or cow's milk allergy;
(3) Infants younger than 8 months of age with an Eczema Area and Severity Index (EASI) score of 7 or higher.
Participant flow
A total of 101 infants with atopic dermatitis were recruited. Blood sampling, clinical examination, and questionnaires were conducted at 4, 7, 10, and 12 months of age. At 12 months, oral food challenge (OFC) tests with hen's egg and cow's milk were performed. Eighty-five infants who completed all assessments were included in the final analysis.
Adverse events
none
Outcome measures
Primary Outcomes
Presence or absence of IgE-mediated allergy to hen's egg or cow's milk at 12 months of age, as determined by oral food challenge (OFC)
Longitudinal measurement of allergen-specific IgE and IgG subclasses (IgG1, IgG2, IgG3, IgG4) to hen's egg and cow's milk allergens and avidity of IgE at 4, 7, 10, and 12 months of age
Secondary Outcomes
Comparison of eczema severity and changes in specific IgE/IgE avidity at 7 months of age between infants who developed food allergy and those who did not
Eczema severity and related biomarkers (EASI score, serum TARC) at 4, 7, 10, and 12 months of age
Anaphylaxis Scoring Aichi (ASCA) score and TS/Pro (total ASCA score per cumulative protein dose) during OFC
Intake status and allergic symptoms related to foods other than hen's egg and cow's milk
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
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047474
