UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019974
Receipt number	R000023063
Scientific Title	Usefulness of exercise challenge for the diagnosis of food-dependent exercise-induced anaphylaxis and the determination of causative food allergen in children
Date of disclosure of the study information	2015/11/28
Last modified on	2020/12/25 07:42:05

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Basic information

Public title

Usefulness of exercise challenge for the diagnosis of food-dependent exercise-induced anaphylaxis and the determination of causative food allergen in children

Acronym

Usefulness of exercise challenge for the diagnosis of food-dependent exercise-induced anaphylaxis in children (UED-FDEIAnC)

Scientific Title

Usefulness of exercise challenge for the diagnosis of food-dependent exercise-induced anaphylaxis and the determination of causative food allergen in children

Scientific Title:Acronym

Usefulness of exercise challenge for the diagnosis of food-dependent exercise-induced anaphylaxis in children (UED-FDEIAnC)

Region

Japan

Condition

Food-dependent exercise-induced anaphylaxis : FDEIAn

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The main purpose of this study is to clarify whether exercise challenge after taking both suspicious food of FDEIAn and NSAIDs can induce symptoms of anaphylaxis. We also evaluate the severeity of the symptoms.

Basic objectives2

Others

Basic objectives -Others

The symptoms of FDEIAn do not appear when only taking causative foods, but they do when combining both exercise and oral intake of NSAIDs after eating foods. For the improvement of patients' QOL, it is inevitable to clarify causative foods for the symptoms. To make a definite diagnosis of FDEIAn, provocation tests are desirable except for those with most severe symptoms.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

To clarify whether allergic symptoms occur or not by the exercise provocation test after both eating suspicious foods and taking oral NSAIDs.

Key secondary outcomes

Disease severity evaluation of the caused symptom

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Food Other

Interventions/Control_1

First, exercise challenge without taking suspicious food is performed in order to ensure that anaphylaxis does not occur by exercise alone. During the challenge, vital signs and appearance of allergic symptoms are checked every 15 min up to 2hours. When anaphylactic symptoms appear, specific treatments including inhalation of bronchodilators and systemic antihistamines will be selected according to the symptoms. Intramuscular adrenalin injections will be done, if necessary.

Interventions/Control_2

Second, oral challenge with suspicious food challenge alone is performed in order to ensure that anaphylaxis does not occur by oral intake alone. During the challenge, vital signs and appearance of allergic symptoms are checked every 15 min up to 2hours. When anaphylactic symptoms appear, specific treatments including inhalation of bronchodilators and systemic antihistamines will be selected according to the symptoms. Intramuscular adrenalin injections will be done, if necessary.

Interventions/Control_3

The subjects take 5-10 mg/kg of acetylsalicylic acid (500 mg as the maximum dose) 30 minutes before oral challenge with suspicious food. Thirty minutes after food intake, exercise challenge test starts. As instruments for exercise, a treadmill or a bicycle ergometer is employed. When using a treadmill, we employ the Bruce method. We change the quantity of the load depending upon age or an athletic capability. Fully running is also employed if the family wants to do it. In this case, approximately 6min load will be made. During the challenge, vital signs and appearance of allergic symptoms are checked every 15 min up to 2hours. When anaphylactic symptoms appear, specific treatments including inhalation of bronchodilators and systemic antihistamines will be selected according to the symptoms. Intramuscular adrenalin injections will be done, if necessary.

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

We perform this challenge test for the subjects who are regularly visiting our hospital regularly for the temporary diagnosis of FDEIAn, or those who have been introduced to our hospital with histories of allergic symptoms caused by exercise after eating suspicious food.

Key exclusion criteria

Patients having a heart trouble or active infectious diseases, and those during asthmatic attacks are excluded. Poorly controlled patients with atopic dermatitis are also excluded

Target sample size

Research contact person

Name of lead principal investigator

1st name Kenichi

Middle name

Last name Tokuyama

Organization

Saitama medical university Hospital

Division name

Pediatrics

Zip code

3500495

Address

38 Morohonngou, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan

TEL

+81-49-276-1218

Email

morita_e@saitama-med.ac.jp

Public contact

Name of contact person

1st name Eiji

Middle name

Last name Morita

Organization

Saitama medical university Hospital

Division name

Pediatrics

Zip code

3500495

Address

38 Morohonngou, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan

TEL

+81-49-276-1218

Homepage URL

Email

morita_e@saitama-med.ac.jp

Sponsor or person

Institute

Department of pediatrics in Saitama medical university Hospital

Institute

Department

Personal name

Funding Source

Organization

Not applicable

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

The Institutional Review Board of Saitama Medical University Hospital

Address

38 Morohonngou, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan

Tel

+81-49-276-1111

Email

hirb@saitama-med.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 28 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

2015 Year 11 Month 28 Day

Date of IRB

2016 Year 03 Month 07 Day

Anticipated trial start date

2015 Year 11 Month 30 Day

Last follow-up date

2020 Year 12 Month 25 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2015 Year 11 Month 28 Day

Last modified on

2020 Year 12 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023063

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name