UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
Title of the study (Brief title)	A randomized study in oral immunotherapy (OIT) for food allergy
Region	Japan

Condition
Condition	food allergy
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of our study are to perform our rush oral immunotherapy (OIT) for children with severe food allergy, to evaluate the safety and efficacy of this method, and to analyze the mechanisms of desensitization and tolerance to food in this method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A comparison of the dose response to double-blind, placebo-controlled food challenge (DBPCFC) before and after therapy between rush OIT group and elimination group. We will define the thresholds for clinically significant reactions in DBPCFC.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	rush oral immunotherapy
Interventions/Control_2	allergen avoidance diet
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	1) children (ages 5-15 years). 2) patients with immediate allergic reactions to egg or milk. 3) egg: the threshold dose inducing allergic reactions <= 4 g. milk: the threshold dose inducing allergic reactions <= 10 ml. 4) available to verbal communication and hospitalization.
Key exclusion criteria	1) patients who have been treated with rush oral immunotherapy. 2) patients with poorly controlled asthma or atopic dermatitis.
Target sample size	40

Research contact person
Name of lead principal investigator	Tsutomu Iwata
Organization	Mie National Hospital
Division name	Institute for Clinical Research
Address	357 Osatokubotatyo, Tsu-City , Mie, 514-0125 JAPAN
TEL	059-232-2531
Email	iwped-tky@umin.ac.jp

Public contact
Name of contact person	Naoka Itoh
Organization	The University of Tokyo
Division name	Department of Pediatrics
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 JAPAN
TEL	03-3815-5411
Homepage URL
Email	naoka_i@hotmail.com

Sponsor
Institute	Mie National Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	国立病院機構 三重病院（三重県） 千葉大学医学部附属病院（千葉県） 千葉県こども病院（千葉県） 国立病院機構 下志津病院（千葉県） 群馬大学医学部附属病院（群馬県） 獨協医科大学病院（栃木県） 富山大学附属病院（富山県） 大阪府立呼吸器アレルギー医療センター（大阪府） あいち小児保健医療総合センター (愛知県）

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 07 Month 23 Day
Anticipated trial start date	2010 Year 07 Month 26 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	2010 Year 07 Month 23 Day
Last modified on	2017 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004740