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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032653
Receipt No. R000037231
Scientific Title Efficacy of oral steroids to treat the immediate symptoms of food allergy
Date of disclosure of the study information 2018/05/20
Last modified on 2019/05/21

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Basic information
Public title Efficacy of oral steroids to treat the immediate symptoms of food allergy
Acronym Efficacy of steroids to treat the immediate symptoms of food allergy
Scientific Title Efficacy of oral steroids to treat the immediate symptoms of food allergy
Scientific Title:Acronym Efficacy of steroids to treat the immediate symptoms of food allergy
Region
Japan

Condition
Condition Food Allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of steroids to treat the immediate symptoms of food allergy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge according to intention to treat analysis
Key secondary outcomes The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge according to per protocol analysis.
The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge, while excluding cases where the ASCA score deteriorated by 10 points or more before the administration of any drugs.
The analysis of the efficacy of steroids was stratified according to each organ symptom.
The efficacy of the steroids to suppress anaphylaxis and anaphylaxy shock.
The analysis of the efficacy of steroids corrected by age, sex, past history of asthma and atopic dermatitis, antigen specific-IgE titer etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Taking both anti-histamines and 1 mg/kg predonisolone
Interventions/Control_2 Taking anti-histamins
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
18 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have undergone oral food challenge tests, and demonstrated a skin symptom score of 10 according to the Anaphylaxis Scoring Aichi (ASCA) .
Key exclusion criteria Patients who have a poor physical condition, such as suffering from a cold before undergoing the oral food challenge tests.
Patients who had orally taken antihistamines, leukotriene receptor antagonists, beta 2 stimulants, Th 2 cytokine inhibitors, theophylline, or oral sodium cromoglycate within 72 hours before the oral food challenge tests.
Patients who received oral or intravenous steroids within 2 weeks before undergoing the oral food challenge tests.
Patients that the doctor assessed as being ineligible for other reasons.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Teruaki
Middle name
Last name Matsui
Organization Aichi Children's Health and Medical Center
Division name Department of Allergy
Zip code 474-8710
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Email teruaki_matsui@sk00106.achmc.pref.aichi.jp

Public contact
Name of contact person
1st name Teruaki
Middle name
Last name Matsui
Organization Aichi Children's Health and Medical Center
Division name Department of Allergy
Zip code 474-8710
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Homepage URL
Email teruaki_matsui@sk00106.achmc.pref.aichi.jp

Sponsor
Institute Aichi Children's Health and Medical Center
Institute
Department

Funding Source
Organization Japanese Society of Pediatric Allergy and Clinical Immunology
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 Institutional Review Board of Aichi Children's Health and Medical Center
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
Tel 0562430500
Email jigyo@sk00106.achmc.pref.aichi.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
2018 Year 05 Month 20 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
2018 Year 03 Month 16 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 05 Month 20 Day
Last follow-up date
2020 Year 03 Month 31 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 05 Month 20 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037231

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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