UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019699 |
|---|---|
| Receipt number | R000022757 |
| Scientific Title | Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2015/11/09 11:29:01 |
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Basic information
Public title
Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy
Acronym
Slow and rush oral immunotherapy for patients with food allergies
Scientific Title
Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy
Scientific Title:Acronym
Slow and rush oral immunotherapy for patients with food allergies
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of slow oral immunotherapy combinaed with rush oral immunotherapy for patients with
food allergy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Evaluation of the symptom provocation threshold change at the time of entry and 12 months after the start of oral immunotherapy and frequencies of allergic symptoms during the 12 months.
Key secondary outcomes
1. Analysis of immunologic parameters in blood samples and measurements of prick test at entry, food challenge and 1 year late the entry.
2. Analysis of adverse effects during this clinical study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Cow's milk, hen's egg, wheat, foods caused by allergy.
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
1) The patients that have positive reactions at food challenge
2) The patients that show more than 0.35 UA/ml of specific IgE level and were positive for skin prick test
3) The patients that written informed consent is obtained
Key exclusion criteria
1) severe bronchial asthma
2) severe atopic dermatitis
3) acute severe illenes
4) Decision of ineligibility by a physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Takahashi |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
Address
2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0101
takahasm@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Takahashi |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
Address
2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0101
Homepage URL
takahasm@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
The Mami Mizutani foundation
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022757
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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