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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030059
Receipt No. R000034318
Scientific Title Evaluation of allergenicity of partially hydrolyzed soy formula and oral immunotherapy using the formula in children with soybean allergy
Date of disclosure of the study information 2017/11/22
Last modified on 2019/06/21

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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

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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