UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Studies on the Mechanism of Introduction of Milk Allergy by Slowly Increasing Oral Immunotherapy
Title of the study (Brief title)	Clinical Studies on the Mechanism of Introduction of Milk Allergy by Slowly Increasing Oral Immunotherapy
Region	Japan

Condition
Condition	milk allergy
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Predict introduction of milk allergy by antigen specific T cell test.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The count of antigen-specific T cells in 1 year after the start of oral immunotherapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	intake of milk everyday
Interventions/Control_2	Removal of milk intake
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with milk allergy
Key exclusion criteria	(1)patients with beta inhibitors (2)pregnant (3) patients with unstable severe asthma (less than 70% per second) (4) systemically serious diseases (malignant tumors,autoimmune diseases, immunodeficiency diseases, severe heart diseases, chronic infections, etc.)(5) continuous use of corticosteroid or anticancer drug(6)acute infection
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuto Kondo
Organization	Banbuntane Hotokukai Hospital
Division name	pediatrics
Address	3-6-10,otobashi,nakagawaku,nagoya
TEL	052-323-5649
Email	ykondo@fujita-hu.ac.jp

Public contact
Name of contact person	Yasuto Kondo
Organization	Banbuntane Hotokukai Hospital
Division name	pediatrics
Address	3-6-10,otobashi,nakagawaku,nagoya
TEL	052-323-5649
Homepage URL
Email	ykondo@fujita-hu.ac.jp

Sponsor
Institute	Banbuntane Hotokukai Hospital
Institute
Department

Funding Source
Organization	japan Dairy Association(J-milk)
Organization
Division
Category of Funding Organization	Non profit foundation
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	2018 Year 06 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 06 Month 28 Day
Last follow-up date
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	2018 Year 06 Month 27 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037814