UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029767 |
|---|---|
| Receipt number | 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 21:04:53 |
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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
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
taigar241983@gmail.com
Sponsor or person
Institute
Department of Clinical Research, Mie National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
