UMIN-CTR Clinical Trial

Basic information
Public title	Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Acronym	Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Scientific Title	Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Scientific Title:Acronym	Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Region	Japan

Condition
Condition	Food allergy (Hen's egg,cow's milk,wheat)
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of efficacy between low dose ingestion of responsible food on alternate days and complete elimination therapy for children with food allergy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of threshold of tolerance dose after treatment between low dose ingestion of responsible food on alternate days and complete elimination for food allergy.
Key secondary outcomes	1)Desensitization of food allergy 2)The change of antigen-specific antibody IgE and IgG4 in serum,and result of skin prick test. 3)The change of quarity of life by questionnaire. 4)Incidence of bronchial asthma.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Low dose ingestion of responsible food( a thirty-second of hen's egg for egg allergy,3ml of cow's milk for milk allergy,or 3g of Udon noodles for wheat allergy) on alternate days for 6 months.
Interventions/Control_2	Complete elimination therapy for 6 months.
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	3 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with immediate allergic reactions to hen's egg,cow's milk or wheat. 2)Patients are confirmed obvious positive objective symptoms caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake and the titer of specific IgE is more than 95% positive predictive value at the probability curve. 3)The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a eighth of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 24ml,and that for wheat is more than 3g of Udon noodles and not greater than 24g of that.
Key exclusion criteria	1)The patients who cannot be obtained informed consent by themselves or their guardians. 2)The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg,3ml of cow's milk, or 3g of Udon noodles by oral food challenge test. 3)Patiens with a history of anaphylactic shock caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake. 4)The patiens with poorly controlled asthma or atopic dermatitis. 5)The patient who the attending physician determines inappropriate.
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takanori Imai
Organization	Showa university school of medicine
Division name	Department of pediatrics
Zip code
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8000
Email	ta-imai@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mayu Shimizu
Organization	Showa university school of medicine
Division name	Department of pediatrics
Zip code
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8000
Homepage URL
Email	mayu-shimi@med.showa-u.ac.jp

Sponsor
Institute	Showa university school of medicine,Department of pediatrics
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Reserch
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 11 Month 06 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	Completed
Date of protocol fixation	2014 Year 09 Month 30 Day
Date of IRB	2014 Year 05 Month 26 Day
Anticipated trial start date	2014 Year 10 Month 16 Day
Last follow-up date	2018 Year 12 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	2015 Year 11 Month 06 Day
Last modified on	2020 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022727