UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020088 |
|---|---|
| Receipt number | R000023210 |
| Scientific Title | Research of T cell epitope in wheat allergy for developing hydrolyzed food aimed at oral immunotherapy |
| Date of disclosure of the study information | 2015/12/06 |
| Last modified on | 2023/06/12 22:17:42 |
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Basic information
Public title
Research of T cell epitope in wheat allergy for developing hydrolyzed food aimed at oral immunotherapy
Acronym
Research of T cell epitope in wheat allergy for developing hydrolyzed food aimed at oral immunotherapy
Scientific Title
Research of T cell epitope in wheat allergy for developing hydrolyzed food aimed at oral immunotherapy
Scientific Title:Acronym
Research of T cell epitope in wheat allergy for developing hydrolyzed food aimed at oral immunotherapy
Region
| Japan |
Condition
Condition
wheat allergy
Classification by specialty
| Clinical immunology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research of T cell epitope in wheat allergy and see the difference with B cell epitope.
Basic objectives2
Others
Basic objectives -Others
Stimulating whole blood or PBMCs from wheat allergy patients with wheat allergen or peptides to see the reaction of T cell.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stimulating whole blood or PBMCs from wheat allergy patients with wheat allergen or peptides to see the reaction of T cell. Compare the T cell epitope with B cell epitope. Compare the T cell response of wheat allergy patients with that of healthy controls.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
wheat allergy and control
Key exclusion criteria
N/A
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Kawamoto |
Organization
Gifu University Hospital
Division name
Department of Pediatrics
Zip code
501-1194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-6386
noriok-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Kawamoto |
Organization
Gifu University Hospital
Division name
Department of Pediatrics
Zip code
501-1194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-6386
Homepage URL
noriok-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, 501-1194, Japan
Tel
0582306059
rinri@gifu-u.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case-control study
Patients who visited our hospital after Dec, 2015 and matched the recruiting criteria with written agreement.
Management information
Registered date
| 2015 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
