UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048546 |
|---|---|
| Receipt number | R000055020 |
| Scientific Title | Cross-sectional study to detect factors for development of food protein-induced enterocolitis syndrome induced by hen's egg |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/02/01 09:42:19 |
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Basic information
Public title
Cross-sectional study to detect factors for development of food protein-induced enterocolitis syndrome induced by hen's egg
Acronym
Research to detect factors for development of FPIES induced by hen's egg
Scientific Title
Cross-sectional study to detect factors for development of food protein-induced enterocolitis syndrome induced by hen's egg
Scientific Title:Acronym
Research to detect factors for development of FPIES induced by hen's egg
Region
| Japan |
Condition
Condition
food protein-induced enterocolitis syndrome(FPIES) induced by hen's egg
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect factors for development of FPIES induced by hen's egg
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Month of introduction of hen's egg intake in patients with FPIES induced by hen's egg compared to controls
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. food protein-induced enterocolitis syndrome(FPIES) induced by hen's egg group: patients fulfilled diagnostic criteria in international consensus guideline of FPIES
2. IgE mediated food allergy with hen's egg group: patients with proven sensitization to hen's egg and a history of IgE-mediated hen's egg allergy symptoms
3. Control group: subjects who can intake a half of hen's egg without any allergic reaction.
Key exclusion criteria
1.Patients born at less than 37 weeks' gestation
2.Patients who are deemed by the physician to be unfit to participate in the study due to a serious underlying medical condition
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akashi |
Organization
Keio university school of medicine
Division name
Pediatrics
Zip code
160-8582
Address
35 shinanomachi shunjuku-ku Tokyo
TEL
03-5363-3816
akashi-m0820@keio.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akashi |
Organization
Keio university school of medicine
Division name
Pediatrics
Zip code
160-8582
Address
35 shinanomachi shunjuku-ku Tokyo
TEL
03-5363-3816
Homepage URL
akashi-m0820@keio.jp
Sponsor or person
Institute
Division of pediatrics, Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese society of pediatric allergy and clinical immunology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
aaaaa
Address
35 shinanomachi shunjuku-ku Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.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
| 2022 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055020
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/11/22 | 鶏卵FPIES発症リスク研究 研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
