UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019489 |
|---|---|
| Receipt number | 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 | 2023/05/01 18:52:06 |
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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
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
sugimoto.mayumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 01 | Day |
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
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022536
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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