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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029767
Receipt No. R000033979
Scientific Title Birth cohort study to establish pivotal biomarkers that determine oral tolerance or food allergy in infancy
Date of disclosure of the study information 2017/10/30
Last modified on 2017/10/30

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Basic information
Public title Birth cohort study to establish pivotal biomarkers that determine oral tolerance or food allergy in infancy
Acronym Tolerance or Allegy? : Immunoglobulin Affinity Study
(TAIGA study)
Scientific Title Birth cohort study to establish pivotal biomarkers that determine oral tolerance or food allergy in infancy
Scientific Title:Acronym 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
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Department of Clinical Research
Zip code
Address 357 Ozato-Kubota, Tsu, Mie, Japan
TEL 059-232-2531
Email eosinophilosophy@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Taiga Kobori
Organization Mie National Hospital
Division name Department of Pediatrics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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