UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035743
Receipt number R000040584
Scientific Title A study on critical factor in children with food allergy
Date of disclosure of the study information 2019/02/01
Last modified on 2019/02/01 15:57:40

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Basic information

Public title

A study on critical factor in children with food allergy

Acronym

A study on critical factor in children with food allergy

Scientific Title

A study on critical factor in children with food allergy

Scientific Title:Acronym

A study on critical factor in children with food allergy

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

We investigate what factors are involved in immune tolerance in children with food allergy.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

How the immune response changes in vivo with immune tolerance

Key secondary outcomes

What kind of immunologic mechanism can cause allergic symptoms?
What factors influence the tolerance acquisition delay?


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


Not applicable

Age-upper limit

20 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who visited the outpatient, diagnosed with food allergy by medical history or ingestion of oral food challenge

Key exclusion criteria

Patients diagnosed with immunodeficiency or chromosomal abnormalities
Patients who do not have allergy symptoms only by sensitization
Patient who the research director judged unsuitable as a subject

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yosuke Baba

Organization

Juntendo University Shizuoka Hospital

Division name

Department of Pediatrics

Zip code


Address

Nagaoka 1129, Izunokuni city, Shizuoka, Japan

TEL

055-948-3111

Email

youbaba@juntnedo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yosuke Baba

Organization

Juntendo University Shizuoka Hospital

Division name

Department of Pediatrics

Zip code


Address

Nagaoka 1129, Izunokuni city, Shizuoka, Japan

TEL

055-948-3111

Homepage URL


Email

youbaba@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicine, Department of Pediatrics

Institute

Department

Personal name



Funding Source

Organization

MEXT (Ministry of Education, Culture, Sports, Science and Technology)-Supported Program for the Strategic Research Foundation at Private Universities Japan.

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

順天堂大学医学部附属静岡病院(静岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 02 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

Open public recruiting

Date of protocol fixation

2019 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A prospective non-interventional observational study


Management information

Registered date

2019 Year 02 Month 01 Day

Last modified on

2019 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040584


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name