UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005784 |
|---|---|
| Receipt number | R000006844 |
| Scientific Title | Effect of oral immunotherapy in preschool children with milk allergy; Trial for the detection of prospective markers for the effectiveness |
| Date of disclosure of the study information | 2011/07/05 |
| Last modified on | 2013/09/21 10:41:17 |
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Basic information
Public title
Effect of oral immunotherapy in preschool children with milk allergy;
Trial for the detection of prospective markers for the effectiveness
Acronym
ORIMA study
Scientific Title
Effect of oral immunotherapy in preschool children with milk allergy;
Trial for the detection of prospective markers for the effectiveness
Scientific Title:Acronym
ORIMA study
Region
| Japan |
Condition
Condition
Milk Allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To standardize the oral immunotherapy as a cow milk allergy treatment in children aged 3-5 years with severe milk allergy and to establish a clinical marker of the effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of subjects showing negative reaction for milk provocation test (100 mL) after 1-year intervention.
Key secondary outcomes
1. Changes in threshold at milk provocation test
2. Changes in skin reactions for prick test
3. Peripheral eosinophil cell count
4. Changes in milk specific IgE, IgG, IgG4 levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral immunotherapy (cow milk)
Interventions/Control_2
obserbation
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who show positive reaction (over Grade 1) for the double blinded placebo controlled milk challenge test.
2. Those who show positive milk-specific IgE (> 0.69 UA/mL).
3. Those who can visit our hosputal within 30 minutes at emergency.
Key exclusion criteria
1. Those who have a past history with life threatning milk allergy (anaphylaxy).
2. Uncontrolled asthma.
3. Uncontrolled atopic dermatitis.
4. soy allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Katsunuma |
Organization
The Jikei University Dai-San Hospital
Division name
Department of Pediatrics
Zip code
Address
4-11-1, Izumi-Honcho, Komae City, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei University Dai-San Hospital
Division name
Pediatrics
Zip code
Address
TEL
Homepage URL
tkatsunuma@jikei.ac.jp
Sponsor or person
Institute
Jikei University
Institute
Department
Personal name
Funding Source
Organization
Kawano Masanori Memorial Foundation for Promotion of Pediatrics
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2011 | Year | 07 | Month | 05 | 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
| 2011 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 15 | Day |
Last modified on
| 2013 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006844
| 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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