UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral tolerance for oral allergy syndrome to apple
Title of the study (Brief title)	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	Nakamaru Yuji
Organization	Hokkaido University Hospital
Division name	otorhinolaryngology
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	Nakamaru Yuji
Organization	Hokkaido University Hospital
Division name	otorhinolaryngology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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