UMIN-CTR Clinical Trial

Basic information
Public title	Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Acronym	oral immunotherapy with hypoallergenic formula
Scientific Title	Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Scientific Title:Acronym	oral immunotherapy with hypoallergenic formula
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of oral immunotherapy with hypoallergenic formula for severe milk allergic children.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The improvement of tolerance to milk of children in each study group
Key secondary outcomes	Milk specific-IgE, peripheral basophil activation against milk, milk specific-T cell activation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
Interventions/Control_2	drink extensively hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
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	1 years-old <
Age-upper limit	20 years-old >=
Gender	Male and Female
Key inclusion criteria	Eligible participants were aged 1-20 years with an immediate hypersensitivity reaction after small amount of milk ingestion.
Key exclusion criteria	Use of antihistamines within three days prior to double blind placebo controlled food challenge (DBPCFC) Uncontrolled bronchial asthma. judged inappropriate for this study by doctor
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Urisu Middle name Last name Atsuo
Organization	Fujita Health University, Banbuntane Hotokukai Hospital
Division name	Department of Pediatrics
Zip code	454-0012
Address	3-6-10 Otobashi, Nakagawa Ward, Nagoya Aichi.Japan
TEL	052-323-5649
Email	urisu@fujita-hu.ac.jp

Public contact
1st name of contact person	1st name Chisato Middle name Last name Inuo
Organization	Fujita Health University
Division name	Department of Pediatrics
Zip code	470-1192
Address	1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
TEL	0562-93-2469
Homepage URL	http://www.fujita-hu.ac.jp/~pedia/pg146.html
Email	inuo@mbh.nifty.com

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of Fujita Health University
Address	1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
Tel	0562-93-2139
Email	f-irb@fujita-hu.ac.jp

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	藤田保健衛生大学

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 08 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	No longer recruiting
Date of protocol fixation	2012 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date	2013 Year 02 Month 08 Day
Last follow-up date	2015 Year 06 Month 02 Day
Date of closure to data entry	2015 Year 06 Month 02 Day
Date trial data considered complete	2015 Year 06 Month 02 Day
Date analysis concluded	2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2014 Year 03 Month 08 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015599