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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026266
Receipt No. R000030162
Scientific Title Comparison of effectiveness of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy - investigator-blinded, randomized, parallel group controlled trial -
Date of disclosure of the study information 2017/03/04
Last modified on 2017/11/27

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Basic information
Public title Comparison of effectiveness of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy - investigator-blinded, randomized, parallel group controlled trial -
Acronym EFAIT study:
Exposure Frequency of Allergen in oral ImmunoTherapy
Scientific Title Comparison of effectiveness of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy - investigator-blinded, randomized, parallel group controlled trial -
Scientific Title:Acronym EFAIT study:
Exposure Frequency of Allergen in oral ImmunoTherapy
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of effectiveness and safety of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Difference of amount of intake in oral food challenge after 12 +- 2 months from start of low dose oral immunotherapy between frequent (daily intake) group and intermittent (twice weekly intake) group.
Key secondary outcomes Primary outcome which divided into subgroup of egg allergy and milk allergy.
Difference of Egg white and ovomucoid-sIgE or milk and casein-sIgE after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups.
Difference of Egg white and ovomucoid-sIgE or milk and cazein-sIgG4 after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups.
Difference of increasing rate of amount of intake in oral food challenge from before the OIT to after the OIT between the frequent group and the intermittent group.
Difference of increasing rate of ovomucoid-sIgE in egg allergy and milk-sIgE in milk allergy from before the OIT to after the OIT between the frequent group and the intermittent group.
Difference of the FAQ after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group.
Difference of the VAS scale for degree of difficulty of intake the foods after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 the participants in frequent group intake the allergic food daily in low dose oral immunotherapy
Interventions/Control_2 the participants in intermittent group intake the allergic food twice weekly in low dose oral immunotherapy
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
6 months-old <=
Age-upper limit
72 months-old >
Gender Male and Female
Key inclusion criteria Children aged 6 months or older, 6 years or younger
Children who were diagnosed with a positive by open oral food challenge (OFC) with boiled egg white / milk, which total dose of 1-10 g. Excluding positive only for the symptoms around the oral cavity.
There are blood test results within 3 months of OFC which performed prior to study registration.
Children who can be Track one year and track confirmation OFC one year later.
A person who consented to the study by a substitute person who is a parental author in writing.
Key exclusion criteria Children already doing oral immunotherapy for the relevant foods, including irregular processed goods.
Children who intake the other allergic food for oral immunotherapy within 2 hours of food intake for this trial.
Those with poor control of atopic dermatitis and bronchial asthma.
Children with chronic urticaria.
Children who is planning to move within 1 year.
The cases who have serious complications and doctor determines that it is inappropriate for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Natsume
Organization Hamamatsu University School of Medicine
Division name Pediatrics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2312
Email natsumeo@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Natsume
Organization Hamamatsu University School of Medicine
Division name Pediatrics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2312
Homepage URL
Email natsumeo@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Japanese Society of Pediatric Allergy and Clinical Immunology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Morimachi Hospital
Chutoen General Medical Center
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
2017 Year 03 Month 04 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 03 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 22 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030162

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2017/08/25 (13)症例報告書(CRF)回数研究 Ver1.01 20170221.docx

Research case data
Registered date File name


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