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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033254
Receipt No. R000037913
Official scientific title of the study clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen
Date of disclosure of the study information 2018/07/07
Last modified on 2018/07/03

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Basic information
Official scientific title of the study clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen
Title of the study (Brief title) oral immunotherapy with a very small amount of allergen
Region
Japan

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

Objectives
Narrative objectives1 It aims to establish oral immunotherapy which is safe and highly effective against food allergy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Number of cases that could cause release of the causative food to the remission level within 3 years from the start of oral immunotherapy
Key secondary outcomes Compliance rate of protocol.
Blood test analysis in progress.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Egg:start dose = <0.2g
Milk:start dose = <0.2g
wheat:start dose = <0.2g
Others(e.g. peanuts, fish,)=<0.2g
Start ingestion and gradually increase. Continue for 3 years.
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
1 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Children who have been diagnosed with food allergies and who are judged to be oral immunotherapy for allergy specialized outpatient clinics.
Specific serum IgE positive and obvious history of food allergy/oral food challenge test positive.
Key exclusion criteria 1.Patient with congenital disease such as chromosomal abnormalities.
2.Child with severe complication history (congenital heart disease, childhood blood tumor disease, surgical operation history).
3.Patient with bronchial asthma that applies to the control status "bad".
4.Contraindication example of administration of adrenaline intramuscular injection preparation
5.Other who judged that the research director is inappropriate as the research subject.



Target sample size 60

Research contact person
Name of lead principal investigator Toshiaki Shimizu
Organization Juntendo University Graduate School of Medicine
Division name Department of Pediatrics and Adolescent Medicine
Address Bunkyo-ku,3-1-3
TEL 0338133111
Email tshimizu@juntendo.ac.jp

Public contact
Name of contact person Susumu Yamazaki
Organization Juntendo University Graduate School of Medicine
Division name Department of Pediatrics and Adolescent Medicine
Address Bunkyo-ku, 3-1-3
TEL 0338133111
Homepage URL
Email susumu@juntendo.ac.jp

Sponsor
Institute Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JPN

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 順天堂大学附属順天堂医院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 07 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

Management information
Registered date
2018 Year 07 Month 03 Day
Last modified on
2018 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037913

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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