UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013026
Receipt number R000015083
Scientific Title Oral food challenge test using dry food powder
Date of disclosure of the study information 2014/01/31
Last modified on 2023/02/13 14:15:18

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Basic information

Public title

Oral food challenge test using dry food powder

Acronym

Oral food challenge test using dry food powder

Scientific Title

Oral food challenge test using dry food powder

Scientific Title:Acronym

Oral food challenge test using dry food powder

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of using dry food powder as challenge food on the result and safety of oral food challenge test

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The results of oral food challenge test

Key secondary outcomes

Provoked symptoms during oral food challenge test
Laboratory data of blood exam
Treatments to provoked symptoms


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

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Perform oral food challenge test using dry food powder as challenge food

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases in which oral food challenge test for hen's egg or cow's milk being performed

Key exclusion criteria

Cases in which oral food challenge test for hen's egg or cow's milk not being performed
Cases judged inadequate by medical doctor

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Ebisawa

Organization

National Hospital Organization
Sagamihara National Hospital

Division name

Department of Allergy, Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.

TEL

042-742-8311

Email

mebisawa@foodallergy.jp


Public contact

Name of contact person

1st name Noriyuki
Middle name
Last name Yanagida

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Allergy, Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.

TEL

042-742-7311

Homepage URL


Email

yana@foodallergy.jp


Sponsor or person

Institute

National Hospital Organization
Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research - KAKENHI, Nipponham Foundation

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Aichi Children's Health and Medical Center
Mie National Hospital (National Hospital Organization Mie Hospital)
National Center for Child Health and Development
Kobe City Medical Center General Hospital
Nagano Children's Hospital
National Hospital Organization Kumamoto Medical Center
Miyagi Children's Hospital
Jichi Medical University Saitama Medical Center
Tokyo Medical University Hospital
Aiwa Hospital
Sagamihara Kyodo Hospital
Nagaoka Central General Hospital
Takeda General Hospital
Atsugi City Hospital
Kumamoto Medical Center
Toho University Ohashi hospital
Chogo Center Clinic
Murano Pediatric Allergy department
Komata Allergy Pediatrics Clinic
Iguchi Pediatric Clinic
Ishida Pediatric Clinic doctor

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Sagamihara National Hospital ethical review board

Address

18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa, JAPAN 252-0392

Tel

042-742-8311

Email

222-rinri@mail.hosp.go.jp


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

2014 Year 01 Month 31 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

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 31 Day

Last modified on

2023 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name