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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029742
Receipt No. 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

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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
Institute Department of Clinical Research, Mie National Hospital
Institute
Department

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
URL(English) https://upload.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


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