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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019974
Receipt No. 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 2019/06/01

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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
Condition Food-dependent exercise-induced anaphylaxis : FDEIAn
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

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 3
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 50

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 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
Middle name
Last name Eiji Morita
Organization Saitama medical university Hospital
Division name Pediatrics
Zip code
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
Institute Department of pediatrics in Saitama medical university Hospital
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 11 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
2015 Year 11 Month 28 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.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


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