UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029249 |
|---|---|
| Receipt number | R000033427 |
| Scientific Title | Development of novel allergen-free recipes for food allergy patients |
| Date of disclosure of the study information | 2017/09/24 |
| Last modified on | 2019/03/25 14:40:49 |
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Basic information
Public title
Development of novel allergen-free recipes for food allergy patients
Acronym
Development of novel allergen-free recipes for food allergy patients
Scientific Title
Development of novel allergen-free recipes for food allergy patients
Scientific Title:Acronym
Development of novel allergen-free recipes for food allergy patients
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
establish a method ti evaluate alternative foods for food allergies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects taste and evaluate at the same time.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
how to evaluate dishes from which allergen foods have been removed
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
evaluate 4 items in 5 levels
Key exclusion criteria
not yet entered
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience Department of Nutritional Science
Zip code
156-8502
Address
1-1-1 Sakuragaoka,Setagaya-ku,Tokyo
TEL
03-5477-2455
e3tanaka@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Etsuro |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
Division name
Faculty of Applied Bioscience Department Nutrition Science
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2455
Homepage URL
e3tanaka@nodai.ac.jp
Sponsor or person
Institute
University
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
Tokyo University of Agriculture
Address
1-1-1, Sakuragaoka, Setagaya-ku, Tokyo
Tel
03-5477-2455
e3tanaka@nodai.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
| 2017 | Year | 09 | Month | 24 | 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
33
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
