UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055090 |
|---|---|
| Receipt number | R000062934 |
| Scientific Title | Examination of whether the degree of burden differs depending on the treatment food in dietary guidance for chicken egg allergy |
| Date of disclosure of the study information | 2024/07/27 |
| Last modified on | 2024/07/27 13:18:09 |
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Basic information
Public title
Examination of whether the degree of burden differs depending on the treatment food in dietary guidance for chicken egg allergy
Acronym
Examination of whether the degree of burden differs depending on the treatment food in dietary guidance for chicken egg allergy
Scientific Title
Examination of whether the degree of burden differs depending on the treatment food in dietary guidance for chicken egg allergy
Scientific Title:Acronym
Examination of whether the degree of burden differs depending on the treatment food in dietary guidance for chicken egg allergy
Region
| Japan |
Condition
Condition
hen's egg allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A questionnaire is used to investigate whether there is a difference in the degree of intake burden between foods provided by hospitals and foods prepared at home during the dietary treatment,
Basic objectives2
Others
Basic objectives -Others
Differences depending on the method of serving ingredients
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Difference in OIT Burden Survey Overall Score Between the Two Groups After 10-14 Weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingesting chicken eggs provided by the hospital
Interventions/Control_2
Ingesting heated eggs cooked at home
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
Heated egg oral challenge test prior to initiation of dietary guidance meets the indication criteria
Key exclusion criteria
Poor control of allergic diseases other than food allergies (atopic dermatitis, bronchial asthma, etc.)
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Takaoka |
Organization
Osaka Habikino medical center
Division name
Department of Pediatrics
Zip code
639-0245
Address
3-7-1 Habikino Habikino city
TEL
09017213953
zvb11075@nifty.com
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | T |
Organization
osaka habkino medical center
Division name
Department of pediatrics
Zip code
639-0245
Address
3-7-1 Habikino Habikino city
TEL
0729572121
Homepage URL
zvb11075@nifty.com
Sponsor or person
Institute
Osaka habikino medical center
Institute
Department
Personal name
Funding Source
Organization
Osaka Habikino medical center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
osaka habikino medical center
Address
3-7-1 Habikino Habikino city
Tel
0729572121
zvb11075@nifty.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
| 2024 | Year | 07 | Month | 27 | 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
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062934
