UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Title of the study (Brief title)	SOFT for Egg allergies
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the non-inferiority of elimination-releasing-methods by step up oral food challenge test compared with food instruction.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the proportion of patient who can ingest 20g of boiled egg white without symptom.
Key secondary outcomes	The amount of boiled egg white that the patients can ingested without symptom at the end of the protocol. Safety of this protocol and compliance of the subjects. The changes in value of laboratory data (e.g. specific IgE titer). The changes in score of anxiety (the state-trait anxiety in ventory).

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Step up oral food challenge test
Interventions/Control_2	dietary instruction
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	4 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who avoid hen's egg containg-food for egg allergy or suspect of egg allergy. Ovomucoid specific IgE titer is class 2 or below. Patients who can eat 2g of boiled egg white in oral food challenge test without obvious allergic symptom.
Key exclusion criteria	patients with severe comorbidities patients with uncontrollable asthma or atopic dermatitis patients with anaphylaxic history by egg ingestion patients who can ingest 2g or more of boiled egg white before oral food challenges patients whom the doctor assess ineligible
Target sample size	100

Research contact person
Name of lead principal investigator	Shiro Sugiura
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Email	bee_jayz@hotmail.com

Public contact
Name of contact person	Katumasa Kitamura
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562430500
Homepage URL
Email	kita0125@gmail.com

Sponsor
Institute	Aichi Children's Health and Medical Center
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 27 Day
Anticipated trial start date	2016 Year 09 Month 27 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 09 Month 30 Day
Date trial data considered complete	2019 Year 09 Month 30 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027845