UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	New product for oral food challenge test in children ;the development and the utility
Title of the study (Brief title)	New product for oral food challenge test in children ;the development and the utility
Region	Japan

Condition
Condition	egg allergy,milk allergy,wheat allergy
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to certify that the test using new product is equal the induced rate, the extent of causing an allergy symptom to the usual test and that the test using new product is more utility than the usual test.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate is that their age,sex,another allergic disease,antigen-specific IgE antibody titer are not difference in the test using new product grop and the usual test group. To certify that the test using new product is equal the induced rate, the extent of causing an allergy symptom to the usual test.
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 not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	The patient is that need to complete remove their target food. High induction rate group,that is the induced rate is over 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012). The test is an usual test.
Interventions/Control_2	The patient is that need to complete remove their target food. High induction rate group,that is the induced rate is over 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012). The test is an using new product.
Interventions/Control_3	The patient is that need to complete remove their target food. Low induction rate group,that is the induced rate is under 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012). The test is an usual test.
Interventions/Control_4	The patient is that need to complete remove their target food. Low induction rate group,that is the induced rate is under 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012). The test is an using new product.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	There is indication of oral food challenge test(Refer to Japanese pediatiric guidline for oral challenge test in Food allergy 2009) and to obtain there consent from the attorney of the child.
Key exclusion criteria	1.The condition of being unstoppable anti-allergy drug,theophylline preparation,steroid drugs. 2.The charge of research judge in an improper the test.
Target sample size	90

Research contact person
Name of lead principal investigator	Natsuki Yoshioka
Organization	St.Marianna university school of medicine
Division name	pediatrics
Address	2-16-1,Sugao miyamae-ku,Kawaski-city,Kanagawa-ken
TEL	044-977-8111
Email	natsuki-desu@marianna-u.ac.jp

Public contact
Name of contact person	Natsuki yoshioka
Organization	St.Marianna university school of medicine
Division name	pediatrics
Address	2-16-1,Sugao miyamae-ku,Kawaski-city,Kanagawa-ken
TEL	044-977-8111
Homepage URL
Email	k-sienbu.mail@marianna-u.ac.jp

Sponsor
Institute	St.Marianna university school of medicine
Institute
Department

Funding Source
Organization	Japan Science and technology agency
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	AJINOMOTO
Name of secondary funｄer(s)	iwamotoseika,A-LIFE

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	聖マリアンナ医科大学病院（神奈川県）、川崎市立多摩病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 08 Month 13 Day
Anticipated trial start date	2013 Year 08 Month 15 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 10 Month 30 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2016 Year 12 Month 30 Day

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

Management information
Registered date	2013 Year 09 Month 26 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013577