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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029249
Receipt No. 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

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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
Email 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
Email e3tanaka@nodai.ac.jp

Sponsor
Institute University
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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