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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017251
Receipt No. R000020025
Scientific Title Oral tolerance for oral allergy syndrome to apple
Date of disclosure of the study information 2015/04/23
Last modified on 2017/05/16

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Basic information
Public title Oral tolerance for oral allergy syndrome to apple
Acronym Oral tolerance for oral allergy syndrome to apple
Scientific Title Oral tolerance for oral allergy syndrome to apple
Scientific Title:Acronym Oral tolerance for oral allergy syndrome to apple
Region
Japan

Condition
Condition Oral allergy syndrome
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of apple consumption for oral tolerance in birch-pollen-induced apple allergy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of patients who can eat 128g of apple.
Key secondary outcomes 1.oral symptom for other meals
2.nasal symptom for birch pollen
3.changes of laboratory findings

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 apple intake 8 month
Interventions/Control_2 Without treatment
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Nasal allergy
Birch-pollen RAST positive
Positeve oral provocation test for apple
Informed concent
Key exclusion criteria Pregnancy
Sever underlying disease
Allergy for nuts and fruits
Severe asthma
Past immune therapy
Positive Rast for Prup 3
others
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakamaru Yuji
Organization Hokkaido University Hospital
Division name otorhinolaryngology
Zip code
Address West5, North 14, Kita-Ku, Sapporo city, Hokkaido
TEL 011-706-5958
Email nmaru@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakamaru Yuji
Organization Hokkaido University Hospital
Division name otorhinolaryngology
Zip code
Address West5, North 14, Kita-Ku, Sapporo city, Hokkaido
TEL 011-706-5958
Homepage URL
Email nmaru@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital otorhinolaryngology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 04 Month 23 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 Completed
Date of protocol fixation
2015 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 23 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
2015 Year 04 Month 23 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020025

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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