UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013026 |
|---|---|
| Receipt number | R000015083 |
| Scientific Title | Oral food challenge test using dry food powder |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2023/02/13 14:15:18 |
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Basic information
Public title
Oral food challenge test using dry food powder
Acronym
Oral food challenge test using dry food powder
Scientific Title
Oral food challenge test using dry food powder
Scientific Title:Acronym
Oral food challenge test using dry food powder
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of using dry food powder as challenge food on the result and safety of oral food challenge test
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of oral food challenge test
Key secondary outcomes
Provoked symptoms during oral food challenge test
Laboratory data of blood exam
Treatments to provoked 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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform oral food challenge test using dry food powder as challenge food
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
Cases in which oral food challenge test for hen's egg or cow's milk being performed
Key exclusion criteria
Cases in which oral food challenge test for hen's egg or cow's milk not being performed
Cases judged inadequate by medical doctor
Target sample size
1000
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, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
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, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-7311
Homepage URL
yana@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research - KAKENHI, Nipponham Foundation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aichi Children's Health and Medical Center
Mie National Hospital (National Hospital Organization Mie Hospital)
National Center for Child Health and Development
Kobe City Medical Center General Hospital
Nagano Children's Hospital
National Hospital Organization Kumamoto Medical Center
Miyagi Children's Hospital
Jichi Medical University Saitama Medical Center
Tokyo Medical University Hospital
Aiwa Hospital
Sagamihara Kyodo Hospital
Nagaoka Central General Hospital
Takeda General Hospital
Atsugi City Hospital
Kumamoto Medical Center
Toho University Ohashi hospital
Chogo Center Clinic
Murano Pediatric Allergy department
Komata Allergy Pediatrics Clinic
Iguchi Pediatric Clinic
Ishida Pediatric Clinic doctor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital ethical review board
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa, JAPAN 252-0392
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
| 2014 | Year | 01 | Month | 31 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015083
