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Recruitment status
Unique ID issued by UMIN UMIN000002139
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Graduate School of Medicine, Gifu University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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