UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034656 |
|---|---|
| Receipt number | R000039505 |
| Scientific Title | Evaluation of lipid concentration in urine and saliva as biomarker for food allergy |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/01/05 17:07:49 |
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Basic information
Public title
Evaluation of lipid concentration in urine and saliva as biomarker for food allergy
Acronym
Biomarker for food allergy
Scientific Title
Evaluation of lipid concentration in urine and saliva as biomarker for food allergy
Scientific Title:Acronym
Biomarker for food allergy
Region
| Japan |
Condition
Condition
Food Allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between lipid concentration in urine and saliva and food allergy symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Prostaglandin D Metabolite in urine 4 hours after ingestion of food and result of double blind placebo-controlled food challenge test.
Key secondary outcomes
1)Correlation between Prostaglandin D2 in saliva and result of double blind placebo-controlled food challenge test.
2)Correlation between Prostaglandin D Metabolite in urine 2,4,6 hours after ingestion of food and result of double blind placebo-controlled food challenge test.
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)children who planning to undergo OFC of egg, milk, and wheat.
2)5-15 years old
3)Children who can autonomously urinate
4)Children who can appeal around the oral symptom
5)Cases with consent
6)Children in which allergic diseases are controlled such as bronchial asthma, atopic dermatitis, allergic rhinitis
Key exclusion criteria
1) Children taking medications affecting PGDM such as NSAIDs.
2) Children taking medicines within 3 days, such as anti-His drugs, anti-leukotriene receptor antagonists, etc., which affect the evaluation of the OFC.
3) Parents can not understand Japanese.
4) Children with severe complications.
5) Other children who thought the doctor was inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Inuzuka |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-12-1 Okura, Setagaya, Tokyo
TEL
03-3416-0181
inuzuka-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Inuzuka |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-12-1 Okura, Setagaya, Tokyo
TEL
03-3416-0181
Homepage URL
inuzuka-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-12-1 Okura, Setagaya, Tokyo
Tel
03-3416-0181
tokunaga-k@ncchd.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039505
