UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013374
Receipt number R000015599
Scientific Title Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Date of disclosure of the study information 2014/03/08
Last modified on 2019/03/12 12:21:00

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Basic information

Public title

Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients

Acronym

oral immunotherapy with hypoallergenic formula

Scientific Title

Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients

Scientific Title:Acronym

oral immunotherapy with hypoallergenic formula

Region

Japan


Condition

Condition

severe milk allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of oral immunotherapy with hypoallergenic formula for severe milk allergic children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The improvement of tolerance to milk of children in each study group

Key secondary outcomes

Milk specific-IgE, peripheral basophil activation against milk, milk specific-T cell activation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting

Interventions/Control_2

drink extensively hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting

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

20 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligible participants were aged 1-20 years with an immediate hypersensitivity reaction after small amount of milk ingestion.

Key exclusion criteria

Use of antihistamines within three days prior to double blind placebo controlled food challenge (DBPCFC)
Uncontrolled bronchial asthma.
judged inappropriate for this study by doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Urisu
Middle name
Last name Atsuo

Organization

Fujita Health University, Banbuntane Hotokukai Hospital

Division name

Department of Pediatrics

Zip code

454-0012

Address

3-6-10 Otobashi, Nakagawa Ward, Nagoya Aichi.Japan

TEL

052-323-5649

Email

urisu@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Chisato
Middle name
Last name Inuo

Organization

Fujita Health University

Division name

Department of Pediatrics

Zip code

470-1192

Address

1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan

TEL

0562-93-2469

Homepage URL

http://www.fujita-hu.ac.jp/~pedia/pg146.html

Email

inuo@mbh.nifty.com


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

IRB of Fujita Health University

Address

1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan

Tel

0562-93-2139

Email

f-irb@fujita-hu.ac.jp


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

藤田保健衛生大学


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 08 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

2012 Year 11 Month 08 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 08 Day

Last follow-up date

2015 Year 06 Month 02 Day

Date of closure to data entry

2015 Year 06 Month 02 Day

Date trial data considered complete

2015 Year 06 Month 02 Day

Date analysis concluded

2018 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 08 Day

Last modified on

2019 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name