UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048552 |
|---|---|
| Receipt number | R000055309 |
| Scientific Title | A study on food reintroduction and preferences after an oral food challenge test of daily intake of eggs, milk, and wheat-a prospective cohort study |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2024/03/26 14:54:54 |
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Basic information
Public title
A study on food reintroduction and preferences after an oral food challenge test of daily intake of eggs, milk, and wheat-a prospective cohort study
Acronym
A study on food reintroduction and preferences after an oral food challenge test of daily intake of eggs, milk, and wheat-a prospective cohort study
Scientific Title
A study on food reintroduction and preferences after an oral food challenge test of daily intake of eggs, milk, and wheat-a prospective cohort study
Scientific Title:Acronym
A study on food reintroduction and preferences after an oral food challenge test of daily intake of eggs, milk, and wheat-a prospective cohort study
Region
| Japan |
Condition
Condition
Egg, milk, and wheat food allergies
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the rate of reintroduction one year after Oral food challenge test in children who underwent oral food challenge test with daily intake of eggs, milk, and wheat.
Basic objectives2
Others
Basic objectives -Others
To investigate whether food allergies are related to food preferences
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between food reintroduction and problem of food preferences
Key secondary outcomes
1. Relationship with factors related to whether food can be reintroduced
2. Relation between the possibility of food reintroduction and the problem of food preferences for egg, milk, wheat
3. Correlation between the specific IgE antibody titer for egg, milk, wheat and the score of food preference problems
4. Percentage with food preferences problems 6 months and 12 months after oral food challenge test of daily intake of eggs, milk and wheat
5. Changes in food preference problems resulting from one-year oral food challenge tests of daily intake and associations with reintroduction
6. Period from oral food challenge test of daily intake of eggs, milk, and wheat to reintroduction
7. Rate of occurrence of allergic symptoms at home 6 months after study enrollment
8. Ratio of STAI before study registration and 6 months after study registration
9. Correlation between anxiety questionnaire and STAI
10. Proportion of people with food preference problems in groups with and without oral immunotherapy
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 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Target age 1-15 years old
2. Oral food challenge test of daily
intake of egg, milk, or wheat was
negative
3. Those who have been subjected to an
oral food challenge test of daily
intake within 2 years after measuring
egg, milk, and wheat-specific IgE
antibody
4) Within 1 month after completion of
daily intake of oral food challenge
test
Key exclusion criteria
1. Those with significant omissions in the
questionnaire
2. Those who are found to have difficulty in
going to the hospital one year later at
the time of study registration
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Masumi |
Organization
Kindai University Faculty of Medicine
Division name
Pediatrics
Zip code
589-8511
Address
377-2, Osasayama, Osaka, Japan
TEL
072-366-0221
hirokimasumi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Masumi |
Organization
Kindai University Faculty of Medicine
Division name
Pediatrics
Zip code
589-8511
Address
377-2, Osasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
hirokimasumi@med.kindai.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2, Osakasayama, Osaka, Japan
Tel
072-366-0221
hirokimasumi@med.kindai.ac.jp
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
市立貝塚病院 (大阪府)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 02 | 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
9
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No special instruction
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: Prospective cohort study
Subjects: 1-15 year old children who visited the research representative facility and the research sharing facility and met the inclusion criteria.
Survey forms, questionnaires, and blood tests (only after 12 months) at study enrollment, 6 months, and 12 months
Survey items: Age, gender, history of induced symptoms and anaphylaxis before Oral food challenge test, duration of food elimination, age in months of first oral food challenge test, presence or absence of allergic disease, family allergy history, white blood cell count, eosinophil percentage, total IgE, Specific IgE antibody
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055309
| 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 |
