UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000027593 |
|---|---|
| Receipt number | R000031625 |
| Scientific Title | Randomized trial of postpartum intake of egg for prevention of egg allergy |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2023/07/11 20:35:07 |
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Basic information
Public title
Randomized trial of postpartum intake of egg for prevention of egg allergy
Acronym
Randomized trial of postpartum intake of egg for prevention of egg allergy
Scientific Title
Randomized trial of postpartum intake of egg for prevention of egg allergy
Scientific Title:Acronym
Randomized trial of postpartum intake of egg for prevention of egg allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether egg ingestion by the mother in the early neonatal period prevents development of immediate type food allergy
Basic objectives2
Others
Basic objectives -Others
Sensitization to egg
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immediate type egg allergy at the age of one
Key secondary outcomes
Sensitization to egg
Onset of other food allergy
Amount of egg protein in breast milk
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Mother ingests one heated egg per day on day 0 to 5 from birth.
Interventions/Control_2
Mother completely eliminates hen's egg on day 0 to 5 from birth.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Infant with high risk of food allergy onset: Infant whom either of parents has an allergic disease (Atopic dermatitis, Bronchial asthma, Food allergy, Allergic rhinitis, Allergic conjunctivitis) on going
Key exclusion criteria
Preterm baby
Birth weight less than 2300g
Severe neonatal asphyxia
Admission to NICU
Infant who has difficulty of ingesting breast milk after 2 days from birth
Decision of ineligibility by a physician
Mother is not able to ingest egg
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
ssakura8010@foodallergy.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nagakura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
k.nagakura@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Jikei University School of Medicine
Tokushima University
Aiwa Hospital
Saitama Medical Center Jichi Medical University
Rokko Island Konan Hospital
National Hospital Organization Nagoya National Hospital
National Hospital Organization Nagara National Hospital
National Hospital Organization Yokohama National Hospital
National Hospital Organization Beppu National Hospital
National Hospital Organization Saitama National Hospital
National Hospital Organization Fukuyama National Hospital
Name of secondary funder(s)
Nipponham Foundation for the Future of Food
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital Ethics Committee
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000031625
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031625
Number of participants that the trial has enrolled
380
Results
<Primary outcome>
Immediate-type egg allergy at 12 months: Maternal egg consumption (MEC) group 9.3% vs Maternal egg elimination (MEE group) 7.6% (Risk ratio 1.22; 95%CI 0.62-2.40)
Results date posted
| 2023 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
380 who were enrolled in the RCT (182 male [47.9%] and 198 female [52.1%]), were divided to the MEC group (190 infants) and the MEE group (190 infants).
Participant flow
Of 414 included infants, 34 were excluded based on the inclusion criteria and exclusion criteria. The remaining 380 infants were enrolled in this RCT.
Adverse events
No adverse effects were obseved.
Outcome measures
The primary outcome was immediate-type egg allergy at 12 months, which was defined as both a positive sensitization to egg white- or OVM-sIgE 0.1 kUA/L or more and a positive test result of OFC or an episode of obvious immediate symptoms after egg ingestion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031625
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/11 | Appendix 4.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/07/11 | Case Data Specifications.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/07/11 | Serious adverse events.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/31625
