UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013027 |
|---|---|
| Receipt number | R000015105 |
| Scientific Title | A cohort study about infantile eczema by observation of its natural course |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2015/03/06 14:51:56 |
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Basic information
Public title
A cohort study about infantile eczema by observation of its natural course
Acronym
A cohort study about infantile eczema
Scientific Title
A cohort study about infantile eczema by observation of its natural course
Scientific Title:Acronym
A cohort study about infantile eczema
Region
| Japan |
Condition
Condition
Food allergy, atopic dermatitis,
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the rate at which children with infantile eczema develop food allergy and risk factors of its development
Basic objectives2
Others
Basic objectives -Others
Natural history
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of food allergy
Key secondary outcomes
The presence of allergic disease
The results of oral food challenge test
Laboratory data of blood exam
The safety of oral food challenge tests
The severity of eczema
The density of environmental antigen of foods
The presence of breast feeding
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
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese breast-fed infants diagnosed with infantile eczema at one month examination in the Department of Pediatrics
Key exclusion criteria
Cases diagnosed no infantile eczema Cases judged inadequate by medical doctor
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Ebisawa |
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, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
foodallergy@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Yanagida |
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, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-7311
Homepage URL
n-yanagida@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Research grant by the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
仙台医療センター（宮城県）、横浜医療センター（神奈川県）、長良医療センター（岐阜県）、福山医療センター（広島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The presence of food allergy
The presence of allergic disease
The results of oral food challenge test
Laboratory data of blood exam
The safety of oral food challenge tests
The severity of eczema
The density of environmental antigen of foods
The presence of breast feeding
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015105
