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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013429
Receipt No. R000015679
Scientific Title Oral Immunotherapy
Date of disclosure of the study information 2014/04/01
Last modified on 2014/04/07

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Basic information
Public title Oral Immunotherapy
Acronym OIT
Scientific Title Oral Immunotherapy
Scientific Title:Acronym OIT
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to establish the effi cacy and safty of OIT for children with food allergy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessing the desensitisation of food allergy
Key secondary outcomes

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 There is a gradual updosing ohase with 1 month to food doses.
Interventions/Control_2 control
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
3 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Participants are aged 3-15 years
Key exclusion criteria They had chronic illness that need high dose steroid.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Sato
Organization Tokyo Medical University
Division name Pediatrics
Zip code
Address 6-7-1 Shinjuku
TEL 03-3342-6111
Email sato115@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Sato
Organization Tokyo Medical University
Division name Pediatrics
Zip code
Address 6-7-1 Shinjuku
TEL 03-3342-6111
Homepage URL
Email sato115@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
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
Address
Tel
Email

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 04 Month 01 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
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 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 03 Month 14 Day
Last modified on
2014 Year 04 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015679

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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