UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Birth cohort study to establish pivotal biomarkers that determine oral tolerance or food allergy in infancy
Title of the study (Brief title)	Tolerance or Allegy? : Immunoglobulin Affinity Study (TAIGA study)
Region	Japan

Condition
Condition	Food allergy
Classification by specialty	Clinical immunology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish novel biomarkers to distinguish development of oral tolerance or that of food allergy by analyzing changes in immune responses to food antigen in early infancy
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between changes in serum levels of food allergen-specific IgE, IgG1, IgG2, IgG3, IgG4, and IgA, antigen affinity of food allergen-specific IgE and IgG1 (measured by highly sensitive DLC/DCP chip assay) in early infancy and oral food challenge outcome (food allergy or tolerance) at 1 year old
Key secondary outcomes	The relationship between other immunological markers and OFC outcome (food allergy or tolerance) at 1 yearold

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	1 days-old <=
Age-upper limit	1 days-old >=
Gender	Male and Female
Key inclusion criteria	All infants who are born at collaborating maternal hospitals and whose parents give informed consent
Key exclusion criteria	Infants who are expected that OFC is not possible at 1 year old by inevitable reasons such as relocation.
Target sample size	150

Research contact person
Name of lead principal investigator	Takao Fujisawa
Organization	Mie National Hospital
Division name	Department of Clinical Research
Address	357 Ozato-Kubota, Tsu, Mie, Japan
TEL	059-232-2531
Email	eosinophilosophy@gmail.com

Public contact
Name of contact person	Taiga Kobori
Organization	Mie National Hospital
Division name	Department of Pediatrics
Address	357 Ozato-Kubota, Tsu, Mie, Japan
TEL	059-232-2531
Homepage URL
Email	taigar241983@gmail.com

Sponsor
Institute	Department of Clinical Research, Mie National Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立病院機構三重病院（三重県）、徳島大学先端酵素学研究所（徳島県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 03 Month 15 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Subjects: All infants who are born at collaborating maternity hospitals and whose parents give informed consent Exclusion:Infants who are expected that OFC at 1 year old is not possible by inevitable reasons such as relocation Serum sampling: mothers in late pregnancy, umbilical cord blood, infants at 2mo, 4mo, 6-7mo, 9-10mo, 12-14mo after birth. Oral food challenge test (egg): at 1 year old.

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033979