UMIN-CTR Clinical Trial

Basic information
Public title	Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Acronym	Outpatient Oral Immunotherapy
Scientific Title	Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Scientific Title:Acronym	Outpatient Oral Immunotherapy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of outpatient oral immunotherapy for food allergy focusing on target doses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The purpose of this study is to clarify dose dependent outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient oral immunotherapy. Patients are enrolled in two groups, which are divided by target amounts of OIT ingestion as 100% or 25% of maximum ingestion amount.
Key secondary outcomes	To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy. To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children. To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy. Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent with its will for participation in advance. The outcome at 2 years' follow up is analyzed in addition to that at 1 year.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The target amount of ingestion, regarding tolerance acquisition, is defined one heated hen's egg, 100ml of cow's milk, and 100g of Japanese Udon noodles.
Interventions/Control_2	The maximum amount of ingestion at home is 100% amount of that in group A and 25% of that in group B, during one year oral immunotherapy.
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	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects, aged 3-15 years old, undergo oral food challenge within the 3 months before this trial. They are confirmed mild or moderate positive objective symptoms caused by hen's egg, cow's milk, or wheat ingestion challenge. The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a quarter of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 25ml, and that for wheat is more than 3g of Udon noodles and not greater than 25g of that.
Key exclusion criteria	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. The subject who is treated by adrenaline injection at oral food challenge test just before this study. The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease. The subject who is not appropriate for oral immunotherapy, judged by medical doctor.
Target sample size	100

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

Public contact
Name of contact person	1st name Middle name Last name Kiyotake Ogura
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL	042-742-7311
Homepage URL
Email	foodallergy@sagamihara-hosp.gr.jp

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	Research grant by the Ministry of Health, Labour and Welfare of Japan
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	国立病院機構　相模原病院　小児科（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 21 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 03 Month 31 Day
Date of IRB	2014 Year 03 Month 18 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry	2018 Year 04 Month 01 Day
Date trial data considered complete	2018 Year 05 Month 01 Day
Date analysis concluded	2018 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 21 Day
Last modified on	2021 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016073