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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019489
Receipt No. R000022536
Scientific Title Oral immunotherapy for children with egg allergy: a randomized controlled trial
Date of disclosure of the study information 2015/12/01
Last modified on 2015/10/25

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Basic information
Public title Oral immunotherapy for children with egg allergy: a randomized controlled trial
Acronym Oral immunotherapy for egg allergy
Scientific Title Oral immunotherapy for children with egg allergy: a randomized controlled trial
Scientific Title:Acronym Oral immunotherapy for egg allergy
Region
Japan

Condition
Condition Food allergy (egg)
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of oral immunotherapy for egg allergy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients with negative results of egg oral food challenge
Key secondary outcomes (1) Change in threshold dose of oral food challenge before and after oral immunotherapy (at registration and 12 months of maintenance phase) in each subject
(2)The frequency of allergic symptoms and rescue drug use
(3)Change in allergen-specific immunoglobulin
(4)Change in QOL by questionnaire

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 NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral immunotherapy with egg
Interventions/Control_2 Oral immunotherapy with egg after 6 months of elimination diet
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
12 years-old >=
Gender Male and Female
Key inclusion criteria Egg allergy patients with threshold of 2 g or more, and 10 g or less in oral food challenge
Key exclusion criteria (1)History of heart, liver and/or renal diseases
(2)Poorly controlled bronchial asthma and/or atopic dermatitis
(3)Patients during oral immunotherapy for other food allergen
(4)Patients whom the doctor assess ineligible
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayumi Sugimoto
Organization Tokushima University Hospital
Division name Department of Pediatrics
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, Japan
TEL 088-633-7135
Email sugimoto.mayumi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi Sugimoto
Organization Tokushima University Hospital
Division name Department of Pediatrics
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima, Japan
TEL 088-633-7135
Homepage URL
Email sugimoto.mayumi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization None
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 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 25 Day
Last modified on
2015 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022536

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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