UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035708 |
|---|---|
| Receipt number | R000040661 |
| Scientific Title | examination of effectiveness and safety of oral immunization for food allergy patients |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2023/02/02 11:27:58 |
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Basic information
Public title
examination of effectiveness and safety of oral immunization for food allergy patients
Acronym
oral immunization for food allergy
Scientific Title
examination of effectiveness and safety of oral immunization for food allergy patients
Scientific Title:Acronym
oral immunization for food allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
determine safety and effectiveness of oral immunotherapy for food allergy patient
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Intake of any dose of allergen without symptom
Key secondary outcomes
Intake of small dose of allergen without symptom
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
taking of allergen 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
| 6 | months-old | <= |
Age-upper limit
| 240 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
complete elimination diet with history of anaphylaxis
Key exclusion criteria
patient who have been produced anaphylaxis by a trace of allergen
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takeshima |
Organization
Hyogo College Of Medicine
Division name
pediatric department
Zip code
663-8501
Address
Mukogawa 1-1,Nishinomiya city,Hyogo pref. Japan
TEL
0798-45-6352
ped-ped@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Tanaka |
Organization
Hyogo College Of Medicine
Division name
pediatric department
Zip code
663-8501
Address
Mukogawa 1-1,Nishinomiya city,Hyogo pref. Japan
TEL
0798-45-6352
Homepage URL
tana-ped@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College Of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College Of Medicine
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
Hyogo College Of Medicine
Address
Mukogawa 1-1,Nishinomiya city,Hyogo pref. Japan
Tel
0798-45-6352
tana-ped@hyo-med.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
| 2019 | Year | 02 | Month | 08 | 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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 02 | 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
Management information
Registered date
| 2019 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040661
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/01/29 | 経口免疫療法・実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
