UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026266 |
|---|---|
| Receipt number | 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 11:34:52 |
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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
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
natsumeo@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
