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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024192
Receipt No. R000027845
Scientific Title Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Date of disclosure of the study information 2016/09/27
Last modified on 2019/01/10

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Basic information
Public title Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Acronym SOFT for Egg allergies
Scientific Title Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Scientific Title:Acronym 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
1st name
Middle name
Last name Shiro Sugiura
Organization Aichi Children's Health and Medical Center
Division name Department of Allergy
Zip code
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Email bee_jayz@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Katumasa Kitamura
Organization Aichi Children's Health and Medical Center
Division name Department of Allergy
Zip code
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)

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
2016 Year 09 Month 27 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027845

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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