UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of allergenicity of partially hydrolyzed soy formula and oral immunotherapy using the formula in children with soybean allergy
Acronym	Allergenicity of partially hydrolyzed soy formula and Immunotherapy for soybean allergy
Scientific Title	Evaluation of allergenicity of partially hydrolyzed soy formula and oral immunotherapy using the formula in children with soybean allergy
Scientific Title:Acronym	Allergenicity of partially hydrolyzed soy formula and Immunotherapy for soybean 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 allergenicity of partially hydrolyzed soy formula compared with soy milk, and to evaluate the efficacy of oral immunotherapy using partially hydrolyzed soy formula.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The threshold dose of soy milk and partially hydrolyzed soy formula in the patient with soybean allergy
Key secondary outcomes	Efficacy and safety at 6 months of oral immunotherapy using partially hydrolyzed soy formula. Change of the basophil activation by oral immunotherapy using partially hydrolyzed soy formula. IgE-immunoblotting and ELISA using the serum of the patients soybeans allegy.

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	Food
Interventions/Control_1	soy milk oral food challenge (1-2-5-10-20 ml, 30 min interval) and partially hydrolyzed soy formula oral food challenge (2-4-10-20-40 ml, 30 min interval ) in the patient with soybean allergy
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	1 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	patient with positive result for soy milk oral food challenge test(1-2-5-10-20 ml, 30 min interval)
Key exclusion criteria	patients during oral immunotherapy for other food antigen. patients with severe comorbidity. patients with uncontrollable asthma or atopic dermatitis. patients who have developed anaphylaxis by soy allergen within one year before the oral food challenge. patients whom the doctor asses ineligible.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Teruaki Matsui
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Zip code
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Email	terumatsu1981@hotmail.com

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

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

Funding Source
Organization	Aichi Children's Health and Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Pediatrics, Fujita Health University Department of Nutrition Management, Nagoya University of Arts and Sciences
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	あいち小児保健医療総合センター（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 22 Day

Related information
URL releasing protocol	http://www.achmc.pref.aichi.jp/clinical/research.html
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	2017 Year 10 Month 01 Day
Date of IRB	2017 Year 11 Month 24 Day
Anticipated trial start date	2017 Year 11 Month 24 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 21 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034318