UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024729
Receipt number R000028442
Scientific Title A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a oral immunotherapy for milk allergy
Date of disclosure of the study information 2016/11/14
Last modified on 2019/05/13 16:31:13

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Basic information

Public title

A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a oral immunotherapy for milk allergy

Acronym

Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy

Scientific Title

A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a oral immunotherapy for milk allergy

Scientific Title:Acronym

Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy

Region

Japan


Condition

Condition

food allergy (milk)

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Oral immunotherapy has been shown to have some efficacy in inducing desensitization for patients with severe unremitting food allergy. However, limitation has also been shown in terms of its side effects and difficulty in inducing tolerance. Safer and more effective therapy is needed.
In this study, to test whether TGF-rich food in combination with oral immunotherapy is effective and safe for milk allergy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Proportion of the subjects who tolerate more than 25 ml of milk (cumulative dose) at oral milk challenge after the treatment for 1 year

Key secondary outcomes

1.Safety: local reaction, systemic immediate-type allergic reaction and other
2.Days:reaching the maintenance dose
3.Prick test
4.Specific IgE and IgG4


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

YES

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Milk-derived TGF-beta-enriched food

Interventions/Control_2

Oral immunotherapy with milk

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

3 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Milk allergy patients definitively diagnosed by oral food challenge with threshold of more than 3ml, and 25 ml or less.

Key exclusion criteria

1) patients who are on other immunotherapy
2)patients who have heart, liver and kidney diseases
3)patients with ncontrolled asthma or atopic dermatitis

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Fujisawa

Organization

National Hospital Organization Mie National Hospital

Division name

Allergy Center

Zip code


Address

357 Osato-kubota, Tsu, Mie, Japan

TEL

+81592322531

Email

fujisawa@mie-m.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yu Kuwabara

Organization

National Hospital Organization Mie National Hospital

Division name

Allergy Center

Zip code


Address

357 Osato-kubota, Tsu, Mie, Japan

TEL

+81592322531

Homepage URL


Email

yu_surrealist@hotmail.co.jp


Sponsor or person

Institute

National Hospital Organization Mie National Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

none


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、国立病院機構相模原病院、福井大学病院、群馬大学病院、獨協医大病院、千葉大学病院、、国立病院機構下志津病院、、千葉県子ども病院、富山大学病院、あいち小児保健医療総合センター、大阪府立呼吸器アレルギー医療センター


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 14 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

Open public recruiting

Date of protocol fixation

2016 Year 10 Month 12 Day

Date of IRB

2016 Year 09 Month 30 Day

Anticipated trial start date

2016 Year 11 Month 15 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 07 Month 31 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 11 Month 06 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name