UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002139 |
|---|---|
| Receipt number | R000002377 |
| Scientific Title | Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2018/09/06 16:17:09 |
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Basic information
Public title
Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides
Acronym
Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides
Scientific Title
Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides
Scientific Title:Acronym
Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides
Region
| Japan |
Condition
Condition
cow's milk allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the intake of the enzyme digested milk peptides or diluted cow's milk induce the tolerance of the patients with cow's milk allergy or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tolerance induction of the patients with cow's milk allergy by taking the enzyme digested milk peptides or cow's milk.
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The patients with cow's milk allergy have enzyme digested milk peptides or diluted milk.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with cow's milk allergy who show the immediate allergic reaction to cow's milk and the specific IgE.
Key exclusion criteria
The patients with cow's milk allergy who have intolerable reaction to enzyme digested milk peptides or diluted cow's milk.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Kondo |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Pediatrics
Zip code
Address
1-1 Yangido, Gifu
TEL
058-230-6386
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Gifu University
Division name
CRM
Zip code
Address
TEL
058-230-6386
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
Research and Development Program for New Bio-industry Initiatives
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 07 | Month | 01 | 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
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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
| 2009 | Year | 06 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002377
