UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034820 |
|---|---|
| Receipt number | R000039614 |
| Scientific Title | Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study. |
| Date of disclosure of the study information | 2018/11/09 |
| Last modified on | 2022/05/13 19:53:00 |
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Basic information
Public title
Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Acronym
Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Scientific Title
Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Scientific Title:Acronym
Quail egg oral food challenge tests in patients allergic to hen's egg: a prospective study.
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether patients allergic to hen's egg diagnosed using an oral food challenge test can ingest quail eggs safely
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who can ingest a quail egg without developing symptoms
Key secondary outcomes
Percentage of children who can safely ingest a quail egg depending on the severity of their hen's egg allergy
Quail egg white- and quail egg yolk-specific IgE and skin prick test to quail egg white results in patients allergic to hen's egg
Quail egg white- and quail egg yolk-specific IgE and skin prick test to quail egg white results in patients allergic to hen's egg with a positive quail egg oral food challenge test
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
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Perform an oral food challenge test with a quail egg within one year of the oral food challenge to hen's egg
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
Positive oral food challenge to hen's egg within one year
Key exclusion criteria
Subjects judged inappropriate for the study by the research director
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Hospital Organization 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, 252-0392
TEL
042-742-8311
aabbk7k7k7@gmail.com
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Mitomori |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
aabbk7k7k7@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
h-furuta@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
| 2018 | Year | 11 | Month | 09 | 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
22
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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039614
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
