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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027593
Receipt No. 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 2019/01/21

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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
Last name of lead principal investigator
1st name
Middle name
Last name Sakura Sato
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email ssakura8010@foodallergy.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Ken-ichi Nagakura
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of pediatrics
Zip code
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email k.nagakura@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

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
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 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
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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 06 Month 01 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031625

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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