UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030059
Receipt number 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 22:45:10

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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 or person

Institute

Aichi Children's Health and Medical Center

Institute

Department

Personal name



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

Value
https://center6.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