UMIN-CTR Clinical Trial

Basic information
Public title	slow specific oral torerance induction used by low allegen cookies for egg allergy
Acronym	slow specific oral torerance induction used by low allegen cookies
Scientific Title	slow specific oral torerance induction used by low allegen cookies for egg allergy
Scientific Title:Acronym	slow specific oral torerance induction used by low allegen cookies
Region	Japan

Condition
Condition	egg allergy patient
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	effcacy of slow specific oral tolerance inductinon used by low allergen cookies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the number of starting to eat more than 0.5g egg white without any symptoms after 4 months oral tolerance inductions
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	oral immunnotherapy by low allergen cookies
Interventions/Control_2	oral immunnotherapy by plasebo cookies
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	12 years-old >=
Gender	Male and Female
Key inclusion criteria	patients unable to eat more than 0.5g egg white by the positive result of oral egg white challenge test
Key exclusion criteria	patients able to eat more than 0.5g egg white by the result of oral egg white challenge test
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name yuri takaoka
Organization	osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic diseases
Division name	department of pediatrics
Zip code
Address	3-7-1 habikino habikino city osaka583-8588japan
TEL	072-957-2121
Email	takaokayu@ra.opho.jp

Public contact
Name of contact person	1st name Middle name Last name yuri takaoka
Organization	osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic
Division name	department of pediatrics
Zip code
Address	3-7-1 habikino habikino city osaka583-8588japan
TEL	072-957-2121
Homepage URL
Email	takaokayu@ra.opho.jp

Sponsor
Institute	osaka prefectual hospital organization osaka prefectural medical center for respiratory and allergic diseases
Institute
Department

Funding Source
Organization	none
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
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	2014 Year 08 Month 23 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 07 Month 01 Day
Date of IRB	2014 Year 02 Month 06 Day
Anticipated trial start date	2014 Year 07 Month 28 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	2014 Year 08 Month 23 Day
Last modified on	2020 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017374