UMIN-CTR Clinical Trial

Basic information
Public title	rush oral immunotherapy of milk allergy
Acronym	rush ofmilk
Scientific Title	rush oral immunotherapy of milk allergy
Scientific Title:Acronym	rush ofmilk
Region	Japan

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

Objectives
Narrative objectives1	oral tolerannce induction of milk allergy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	threthhold level of milk after 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	20ml of milk intake
Interventions/Control_2	100ml 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	15 years-old >=
Gender	Male and Female
Key inclusion criteria	milk allergy
Key exclusion criteria	no milk allergy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yuri Middle name Last name takaoka
Organization	oosaka prefectural respuratory and allergy center
Division name	pediatrics
Zip code	6390245
Address	3-7-1 habikino habikino-city
TEL	072-957-2121
Email	takaokayu@ra.opho.jp

Public contact
Name of contact person	1st name Yuri Middle name Last name takaoka
Organization	oosaka prefectural respuratory and allergy center
Division name	pediatrics
Zip code	5838588
Address	3-7-1 habikino habikino-city
TEL	072-957-2121
Homepage URL
Email	takaokayu@ra.opho.jp

Sponsor
Institute	oosaka prefectural respuratory and allergy center
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	osaka Habikino medical center
Address	3-7-1,Habikino,Habikino City
Tel	0729572121
Email	zvb11075@nifty.com

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	2013 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	33
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	Completed
Date of protocol fixation	2013 Year 01 Month 30 Day
Date of IRB	2013 Year 01 Month 30 Day
Anticipated trial start date	2013 Year 02 Month 18 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 23 Day
Last modified on	2020 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014490