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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048552
Receipt No. 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 2022/08/02

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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
Email 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
Email hirokimasumi@med.kindai.ac.jp

Sponsor
Institute Department of Pediatrics, Kindai University Faculty of Medicine
Institute
Department

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
Email 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
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
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
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055309

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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