UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053850 |
|---|---|
| Receipt number | R000061457 |
| Scientific Title | Consumption of Hen's Egg for Egg allergy Prevention (CHEEP) study |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 14:32:46 |
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Basic information
Public title
Non-randomized controlled trial on the frequency of hen's egg protein ingestion during early infancy and its effect on preventing the development of hen's egg allergy
Acronym
CHEEP study
Scientific Title
Consumption of Hen's Egg for Egg allergy Prevention (CHEEP) study
Scientific Title:Acronym
CHEEP study
Region
| Japan |
Condition
Condition
food allergy, hen's egg allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the effect of frequency of hen's egg protein ingestion in early infancy on the development of hen's egg allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of hen's egg allergy development at 6 months of age
Key secondary outcomes
The proportion of hen's egg sesitization and measurement of hen's egg specific IgE and IgG4 titer at 6 months of age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants of daily ingestion group intake 12.5 mg of hen's egg protein everyday during first 4 weeks at 4 months of age, and 25 mg of hen's egg protein everyday during next 4 weeks. They will be treated their eczema with proactive treatment using topical corticosteroids. They will be performed oral food challenge test at 6 months of age to assess the development of hen's egg allergy.
Interventions/Control_2
Participants of weekly ingestion group intake 12.5 mg of hen's egg protein once a week during first 4 weeks at 4 months of age, and 25 mg of hen's egg protein once a week during next 4 weeks. They will be treated their eczema with proactive treatment using topical corticosteroids. They will be performed oral food challenge test at 6 months of age to assess the development of hen's egg allergy.
Interventions/Control_3
Participants of avoidance group eliminate hen's egg protein up to 6 months of age. They will be treated their eczema with proactive treatment using topical corticosteroids. They will be performed oral food challenge test at 6 months of age to assess the development of hen's egg allergy.
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
| 4 | weeks-old | <= |
Age-upper limit
| 6 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Gestationa age>=35 weeks and birth weight>=2000g
Presence of visible eczema
Key exclusion criteria
Complication of any severe underlying disease
Target sample size
202
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Sakihara |
Organization
Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name
Pediatrics
Zip code
9012492
Address
208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA, Japan
TEL
0988953255
odekorin2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Sakihara |
Organization
Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name
Pediatrics
Zip code
9012492
Address
208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA, Japan
TEL
0988953255
Homepage URL
odekorin2000@yahoo.co.jp
Sponsor or person
Institute
Social medical corporation KARIYUSHIKAI Heartlife Hospital
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation KARIYUSHIKAI Heartlife Hospital
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
Social medical corporation KARIYUSHIKAI Heartlife Hospital Institutional Review Board
Address
208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA 901-2492, Japan
Tel
0988953255
odekorin2000@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 13 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061457
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