UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on induction of oral immune tolerance in children with food allergy
Title of the study (Brief title)	The effect of slow oral immunotherapy on food allergy
Region	Japan

Condition
Condition	Food Allergy
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to find trace amounts that can be ingested by children who present with food allergy symptoms in minimum dose and investigate whether food allergic children acquired immune tolerance by increasing to have food antigen slowly. Whether it can be increased without exhibiting severe allergic symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Children with food allergy can ingest a minimum dose of food antigen.
Key secondary outcomes	Children with food allergy do not develop severe allergic symptoms.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Children who has immediate allergic symptoms in oral food challenge due to minimum dose. 2. Childen diagnosed as having food allergy. 3. The children who gained written consent by free will from the patient himself or the substitute person after having sufficient explanation for participation in this research, with sufficient understanding.
Key exclusion criteria	1. With surgical history such as gastrointestinal resection surgery. 2. With immunodeficiency, bone strain disorder, malformation. 3. Children who judged that the research director is inappropriate as the research subject.
Target sample size	100

Research contact person
Name of lead principal investigator	Yosuke Baba
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Pediatrics
Address	Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL	055-948-3111
Email	youbaba@juntendo.ac.jp

Public contact
Name of contact person	Yosuke Baba
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Pediatrics
Address	Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL	055-948-3111
Homepage URL
Email	youbaba@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization	MEXT (Ministry of Education, Culture, Sports, Science and Technology) Supported Program for the Strategic Research Foundation at Private Universities Japan
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	順天堂大学医学部附属静岡病院（静岡県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 01 Day
Anticipated trial start date	2019 Year 01 Month 01 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	A prospective non-interventional observational study

Management information
Registered date	2019 Year 02 Month 01 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040582

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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