UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027332 |
|---|---|
| Receipt number | R000030365 |
| Scientific Title | Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2021/11/15 19:02:41 |
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Basic information
Public title
Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Acronym
Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Scientific Title
Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Scientific Title:Acronym
Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants
Region
| Japan |
Condition
Condition
Hen's egg allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate in a multicenter placebo controlled randomized trial whether introducing very small amounts of heated hen's egg in severe egg allergic children less than 2 years old induces desensitization and sustained unresponsiveness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients desensitized to 1/8 of heated hen's egg after 6 months, confirmed with a double-blind, placebo-controlled food challenge (DBPCFC)
Key secondary outcomes
Frequency and severity of adverse events at home during the trial.
Changes in egg white and ovomucoid specific IgE, IgG, IgG4 measured before trial and after 6 and 12 months of the trial.
Changes in skin prick test results tested before trial and after 6 and 12 months of the trial.
Sustained unresponsiveness to 1/2 of heated hen's egg within 1.5 years of initiation of the trial.
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of heated hen's egg powder for 6 months. The dose of intake for the initial 1 month is 0.2g of heated hen' egg powder (50mg of egg protein). After 1 month, the intake amount is gradually increased towards the target dose of 1g of heated hen's egg powder (250mg of egg protein).
Interventions/Control_2
Daily intake of placebo powder for 6 months. The dose of intake for the initial 1 month is 0.2g of placebo powder. After 1 month, the intake amount is gradually increased towards the target dose of 1g of placebo powder.
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
| 10 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Positive oral food challenge to 1/32 of heated hen's egg (250mg of egg protein) within 3 months of initiation of the trial.
Capable of consuming 1/160 of heated hen's egg (50mg of egg protein) without allergic symptoms.
Key exclusion criteria
Severe allergic symptoms or symptoms requiring the use of adrenaline during the oral food challenge to 1/32 of heated hen's egg (250mg of egg protein).
Regular intake of hen's egg before initiation of trial.
Severe (uncontrolled) atopic dermatitis before intiation of trial.
Two or more hospitalizations due to wheezing episodes in the previous 6 months before initiation of trial
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Nishino |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japmi-ku Sakuradai 18-1 Sagamihara, Japan
TEL
042-742-8311
Homepage URL
precastudy@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Hospital Organization Sagamihara National Hospital Ethics Committee
Address
18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan, 252-0392
Tel
042-742-8311
h-kushida@sagamihara-hosp.gr.jp
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
国立病院機構相模原病院（神奈川）、国立病院機構三重病院（三重）、あいち小児保健医療総合センター（愛知）、福井大学医学部付属病院（福井)、東京医科大学病院（東京）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 16 | 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
55
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2017 | Year | 05 | Month | 13 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030365
