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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035741
Receipt No. R000040582
Official scientific title of the study A study on induction of oral immune tolerance in children with food allergy
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/22

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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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