UMIN-CTR Clinical Trial

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 symptom score of 10 (skin symptom) or 11 (10 of skin symptom plus 1)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	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/all.15451
Number of participants that the trial has enrolled	103
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	Completed
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	2022 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	2022 Year 08 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037231