UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral immunotherapy in children with cow's milk allergy by enzyme digested milk peptides
Title of the study (Brief title)	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	Naomi Kondo
Organization	Graduate School of Medicine, Gifu University
Division name	Department of Pediatrics
Address	1-1 Yangido, Gifu
TEL	058-230-6386
Email

Public contact
Name of contact person
Organization	Graduate School of Medicine, Gifu University
Division name	CRM
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)

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

Progress
Recruitment status
Date of protocol fixation	2009 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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