UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019671
Receipt number R000022727
Scientific Title Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Date of disclosure of the study information 2015/11/06
Last modified on 2020/02/13 11:08:04

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Basic information

Public title

Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Acronym

Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Scientific Title

Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Scientific Title:Acronym

Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Region

Japan


Condition

Condition

Food allergy
(Hen's egg,cow's milk,wheat)

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of efficacy between low dose ingestion of responsible food on alternate days and complete elimination therapy for children with food allergy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of threshold of tolerance dose after treatment between low dose ingestion of responsible food on alternate days and complete elimination for food allergy.

Key secondary outcomes

1)Desensitization of food allergy
2)The change of antigen-specific antibody IgE and IgG4 in serum,and result of skin prick test.
3)The change of quarity of life by questionnaire.
4)Incidence of bronchial asthma.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Low dose ingestion of responsible food(
a thirty-second of hen's egg for egg allergy,3ml of cow's milk for milk allergy,or 3g of Udon noodles for wheat allergy) on alternate days for 6 months.

Interventions/Control_2

Complete elimination therapy for 6 months.

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


Not applicable

Age-upper limit

3 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients with immediate allergic reactions to hen's egg,cow's milk or wheat.
2)Patients are confirmed obvious positive objective symptoms caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake and the titer of specific IgE is more than 95% positive predictive value at the probability curve.
3)The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a eighth of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 24ml,and that for wheat is more than 3g of Udon noodles and not greater than 24g of that.

Key exclusion criteria

1)The patients who cannot be obtained informed consent by themselves or their guardians.
2)The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg,3ml of cow's milk, or 3g of Udon noodles by oral food challenge test.
3)Patiens with a history of anaphylactic shock caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake.
4)The patiens with poorly controlled asthma or atopic dermatitis.
5)The patient who the attending physician determines inappropriate.

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanori Imai

Organization

Showa university school of medicine

Division name

Department of pediatrics

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8000

Email

ta-imai@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mayu Shimizu

Organization

Showa university school of medicine

Division name

Department of pediatrics

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8000

Homepage URL


Email

mayu-shimi@med.showa-u.ac.jp


Sponsor or person

Institute

Showa university school of medicine,Department of pediatrics

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Reserch

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 06 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

Completed

Date of protocol fixation

2014 Year 09 Month 30 Day

Date of IRB

2014 Year 05 Month 26 Day

Anticipated trial start date

2014 Year 10 Month 16 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 06 Day

Last modified on

2020 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022727


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name