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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033391
Receipt No. R000038071
Scientific Title the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy
Date of disclosure of the study information 2018/07/14
Last modified on 2018/07/14

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Basic information
Public title the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy
Acronym rush oral immunotherapy of wheat allergy
Scientific Title the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy
Scientific Title:Acronym rush oral immunotherapy of wheat allergy
Region
Japan

Condition
Condition wheat allergy patients
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate that omega-5 gliadin specifc IgE titer can predict the proper maintenace dose of rash oral immunotherapy of wheat allergy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ]
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 30g of meintenance dose
Interventions/Control_2 choice of 5g,10g or 30g of maintenance dose according to omega-5 gliadin specific IgE titer
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
5 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria wheat allergy
Key exclusion criteria rash immunotherapy of other food
heat,liver and kidney disease
uncontrolled bronchial asthma and atopic dermatitis
IgA deficiency
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuri Takaoka
Organization osaka Habikino medical center
Division name department of pediatrics
Zip code
Address 3-7-1 Habikino Habikino city
TEL 0729572121
Email zvb11075@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuri Takaoka
Organization osaka Habikino medical center
Division name department of pediatrics
Zip code
Address 3-7-1 Habikino Habikino city
TEL 0729572121
Homepage URL
Email zvb11075@nifty.com

Sponsor
Institute osaka Habikino medical center
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
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
2018 Year 07 Month 14 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
2018 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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
2018 Year 07 Month 14 Day
Last modified on
2018 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038071

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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