UMIN-CTR Clinical Trial

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
Email	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
Email	inuzuka-y@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039505