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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041637
Receipt No. R000047483
Scientific Title A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Date of disclosure of the study information 2020/09/02
Last modified on 2020/09/01

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Basic information
Public title A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Acronym Low-dose oral immunotherapy for preschool-aged children
Scientific Title A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Scientific Title:Acronym Low-dose oral immunotherapy for preschool-aged children
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of low-dose oral immunotherapy for preschool-aged children with food allergy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of negative oral food challenge to the low-dose* after 1 year
*The low-dose is defined as"1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut"
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The target amount of ingestion is defined as 1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut.
The subjects are asked to take a small amount of their causative food at the inpatient department. The amount is gradually built up to their target amount depending on their symptoms.
The subjects continue to ingest their causative foods for a year after discharge from the hospital.
Interventions/Control_2 The subjects continue to eliminate their causative foods for a year.
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
3 years-old <=
Age-upper limit
5 years-old >=
Gender Male and Female
Key inclusion criteria Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of milk, and 2g of udon, 0.5g of peanut.
Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.).
Key exclusion criteria The subject who has poorly treated atopic dermatitis and bronchial asthma.
The subject suspected with Food-protein induced enterocolitis syndrome.
The subject whose body weight is less than 10 kg.
The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.
Target sample size 96

Research contact person
Name of lead principal investigator
1st name Motohiro
Middle name
Last name Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code 252-0392
Address 18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL 042-742-8311
Email mebisawa@foodallergy.jp

Public contact
Name of contact person
1st name Ken-ichi
Middle name
Last name Nagakura
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code 252-0392
Address 18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan
TEL 042-742-8311
Homepage URL
Email k.nagakura@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Sagamihara National Hospital
Address 18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
Tel 042-742-8311
Email 222-rinri@mail.hosp.go.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 06 Month 30 Day
Date of IRB
2020 Year 07 Month 21 Day
Anticipated trial start date
2020 Year 09 Month 03 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 01 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047483

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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