UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003943
Receipt number 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 16:14:02

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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 or person

Institute

Mie National Hospital

Institute

Department

Personal name



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

Value
https://center6.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