UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003943
Receipt No. R000004740
Scientific Title A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
Date of disclosure of the study information 2010/07/23
Last modified on 2017/01/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
Acronym A randomized study in oral immunotherapy (OIT) for food allergy
Scientific Title A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
Scientific Title:Acronym A randomized study in oral immunotherapy (OIT) for food allergy
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of our study are to perform our rush oral immunotherapy (OIT) for children with severe food allergy, to evaluate the safety and efficacy of this method, and to analyze the mechanisms of desensitization and tolerance to food in this method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A comparison of the dose response to double-blind, placebo-controlled food challenge (DBPCFC) before and after therapy between rush OIT group and elimination group. We will define the thresholds for clinically significant reactions in DBPCFC.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 rush oral immunotherapy
Interventions/Control_2 allergen avoidance diet
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
5 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) children (ages 5-15 years).
2) patients with immediate allergic reactions to egg or milk.
3) egg: the threshold dose inducing allergic reactions <= 4 g.
milk: the threshold dose inducing allergic reactions <= 10 ml.
4) available to verbal communication and hospitalization.
Key exclusion criteria 1) patients who have been treated with rush oral immunotherapy.
2) patients with poorly controlled asthma or atopic dermatitis.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Iwata
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code
Address 357 Osatokubotatyo, Tsu-City , Mie, 514-0125 JAPAN
TEL 059-232-2531
Email iwped-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoka Itoh
Organization The University of Tokyo
Division name Department of Pediatrics
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 JAPAN
TEL 03-3815-5411
Homepage URL
Email naoka_i@hotmail.com

Sponsor
Institute Mie National Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 国立病院機構 三重病院(三重県)
千葉大学医学部附属病院(千葉県)
千葉県こども病院(千葉県)
国立病院機構 下志津病院(千葉県)
群馬大学医学部附属病院(群馬県)
獨協医科大学病院(栃木県)
富山大学附属病院(富山県)
大阪府立呼吸器アレルギー医療センター(大阪府)
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
2010 Year 07 Month 23 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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 23 Day
Last modified on
2017 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.