UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029742
Receipt number R000033945
Scientific Title Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children
Date of disclosure of the study information 2017/10/28
Last modified on 2017/10/31 12:18:00

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Basic information

Public title

Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children

Acronym

Immunoglobulin Maturation and Affinity Kinetics in Immunotherapy for Food Allergy (IMAKIFA) Study

Scientific Title

Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children

Scientific Title:Acronym

Immunoglobulin Maturation and Affinity Kinetics in Immunotherapy for Food Allergy (IMAKIFA) Study

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether changes in serum levels and antigen affinity of allergen-specific IgE and IgG subclasses reflect treatment response to oral immunotheapy for food allergy

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Association of serum levels of allergen-specific IgE, IgG1, IgG2, IgG3, IgG4 and IgA(measured by highly sensitive DLC/DCP chip assay), antigen affinity of IgE and IgG1 (by competition binding assay using DLC/DCP chip) and desensitization levels (tolerable amount of food) induced by oral immunotherapy

Key secondary outcomes

Association of other immonological markers (basophil activation, urinary prostaglandin etc) and desensitization levels (tolerable amount of food) induced by oral immunotherapy


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with food allergy who undergo rush oral immunotherapy

Key exclusion criteria

1.patients with any chronic disease other than allergic diseases
2.patients with uncontrolled asthma or atopic dermatitis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Fujisawa

Organization

Mie National Hospital

Division name

Department of Clinical Research

Zip code


Address

357 Ozato- Kubota, Tsu, Mie, Japan

TEL

059-232-2531

Email

eosinophilosophy@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Imakiire

Organization

Mie National Hospital

Division name

Department of Pediatrics

Zip code


Address

357 Ozato- Kubota, Tsu, Mie, Japan

TEL

059-232-2531

Homepage URL


Email

iamluckymanjp@yahoo.co.jp


Sponsor or person

Institute

Department of Clinical Research, 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



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)、徳島大学先端酵素学研究所(徳島県)


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 28 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

2017 Year 10 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 28 Day

Last follow-up date

2020 Year 02 Month 28 Day

Date of closure to data entry

2020 Year 03 Month 15 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 04 Month 30 Day


Other

Other related information

Subjects: patients with food allergy who undergo oral immunotherapy (OIT)
Blood sampling: before OIT, at 1 week and 2 weeks during dose-escalation phase, at completion of dose-escalation phase(=start of maintenance phase), at 3mo, 6mo and 12mo during maintenance phase
Treatment outcome: amount of allergen food achieved at completion of dose-escalation phase and at 12mo in maintenance phase
Adverse events: induced allergic symptoms by OIT, severity of the symptoms


Management information

Registered date

2017 Year 10 Month 27 Day

Last modified on

2017 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033945


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name