UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034085
Receipt number R000038858
Scientific Title Oral food challenge test for food-allergic children at outpatient clinic
Date of disclosure of the study information 2018/10/02
Last modified on 2019/03/28 18:42:50

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Basic information

Public title

Oral food challenge test for food-allergic children at outpatient clinic

Acronym

Oral food challenge test for food-allergic children at outpatient clinic

Scientific Title

Oral food challenge test for food-allergic children at outpatient clinic

Scientific Title:Acronym

Oral food challenge test for food-allergic children at outpatient clinic

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To provide precise nutritional guidance of each allergens.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To provide remission of allergens

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To eat allergens

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

6 years-old <=

Age-upper limit

16 years-old >

Gender

Male and Female

Key inclusion criteria

Food allergy patient who is not likely to have symptoms by eating allergens.

Key exclusion criteria

Food allergy patient who is likely to have symptoms by eating allergens.

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Tokuyama

Organization

Saitama medical university hospital

Division name

Pediatrics

Zip code


Address

morohongo38, moroyama-cho, iruma-gun, Saitama-prf

TEL

049-276-1218

Email

y_ueda@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ueda Yutaka

Organization

Saitama Medical University Hospital

Division name

Pediatrics

Zip code


Address

morohongo38, moroyama-cho, iruma-gun, Saitama-prf

TEL

049-276-1218

Homepage URL


Email

y_ueda@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Hospital,
department of pediatrics

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Hospital,
department of pediatrics

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 02 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

Terminated

Date of protocol fixation

2018 Year 08 Month 31 Day

Date of IRB

2019 Year 01 Month 07 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 10 Day

Last modified on

2019 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name