UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033391
Receipt number R000038071
Scientific Title the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy
Date of disclosure of the study information 2018/07/14
Last modified on 2020/06/11 11:53:53

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Basic information

Public title

the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy

Acronym

rush oral immunotherapy of wheat allergy

Scientific Title

the relationship between omega-5 gliadin specific IgE titer and maintenance dose of rush oral immunotherapy of wheat allergy

Scientific Title:Acronym

rush oral immunotherapy of wheat allergy

Region

Japan


Condition

Condition

wheat allergy patients

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate that omega-5 gliadin specifc IgE titer can predict the proper maintenace dose of rash oral immunotherapy of wheat allergy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of the number of days of provoked symptoms
Comparison of reaching the maintenance dose in the build-up phase

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

30g of meintenance dose

Interventions/Control_2

choice of 5g,10g or 30g of maintenance dose according to omega-5 gliadin specific IgE titer

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

wheat allergy

Key exclusion criteria

rash immunotherapy of other food
heat,liver and kidney disease
uncontrolled bronchial asthma and atopic dermatitis
IgA deficiency

Target sample size

40


Research contact person

Name of lead principal investigator

1st name yuri
Middle name
Last name Takaoka

Organization

osaka Habikino medical center

Division name

department of pediatrics

Zip code

5838588

Address

3-7-1 Habikino Habikino city

TEL

0729572121

Email

zvb11075@nifty.com


Public contact

Name of contact person

1st name Yuri
Middle name
Last name Takaoka

Organization

osaka Habikino medical center

Division name

department of pediatrics

Zip code

5838588

Address

3-7-1 Habikino Habikino city

TEL

0729572121

Homepage URL


Email

zvb11075@nifty.com


Sponsor or person

Institute

osaka Habikino medical center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

osaka Habikino medical center

Address

3-7-1,Habikino,Hbikino City

Tel

0729572121

Email

zvb11075@nifty.com


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

2018 Year 07 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

Enrolling by invitation

Date of protocol fixation

2018 Year 05 Month 08 Day

Date of IRB

2018 Year 04 Month 23 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2026 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

2018 Year 07 Month 14 Day

Last modified on

2020 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name