UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053816 |
|---|---|
| Receipt number | R000061422 |
| Scientific Title | Clinical safety of allergy-reduced eggs in patients with severe hen's egg allergy |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/09 18:09:08 |
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Basic information
Public title
Clinical safety of allergy-reduced eggs in patients with severe hen's egg allergy
Acronym
Clinical safety of allergy-reduced eggs in patients with severe hen's egg allergy
Scientific Title
Clinical safety of allergy-reduced eggs in patients with severe hen's egg allergy
Scientific Title:Acronym
Clinical safety of allergy-reduced eggs in patients with severe hen's egg allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether patients with hen's egg allergy develop symptoms when ingesting ovomucoid-free hen's egg.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of positive results in the oral food challenge using heated ovomucoid-free hen's egg.
Key secondary outcomes
(1) Egg white-specific IgE level
(2) Ovomucoid-specific IgE level
(3) Severity of symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients undergo an oral food challenge using heated ovomucoid-free hen's egg foods and patients who passing an oral food challenge of heated ovomucoid-free hen's egg foods ingest the same foods several times at home.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with allergic symptoms to less than one-eighth of a heated hen's egg in oral food challenge.
Key exclusion criteria
(1) Patients who received systemic steroid medication (1mg/kg/day or more) for more than 7 days within 3 months prior to the oral food challenge.
(2) Patients receiving anti-IgE antibody, anti-IL-5 antibody, anti-IL-5 receptor antibody, anti-IL-4/IL-13 receptor antibody, or JAK inhibitor (oral).
(3) Decision of ineligibility by a physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
NHO Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Ozeki |
Organization
NHO Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
rui.ozeki11@gmail.com
Sponsor or person
Institute
NHO Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kewpie Corporation
Hiroshima university graduate school of integrated sciences for life
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
Tel
042-742-8311
222-rinri@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 11 | 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
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 26 | 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 | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061422
| Research Plan | |
|---|---|
| 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 |
