UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a rush oral immunotherapy for milk allergy
Title of the study (Brief title)	Effect of adjunctive TGF-rich food in rush oral immunotherapy for milk allergy
Region	Japan

Condition
Condition	food allergy (milk)
Classification by specialty	Medicine in general Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test whether TGF-rich food in combination with oral immunotherapy is effective and safe for milk allergy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Change in threshold of oral food challenge test
Key secondary outcomes	Number of adrenaline use for severe induced symptoms

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	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Milk-derived TGF-beta-enriched food
Interventions/Control_2	Oral immunotherapy with milk
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 patients definitively diagnosed by oral food challenge with threshold of above 1ml, and 10 ml or less.
Key exclusion criteria	1) Allergy to soy bean or dextrin, which are contained in placebo 2) Poorly controlled bronchial asthma and/or atopic dermatitis (If controlled with optimal pharmaceutical therapy, not excluded)
Target sample size	40

Research contact person
Name of lead principal investigator	Takao Fujisawa
Organization	Mie National Hospital
Division name	Allergy Center
Address	357 Osato-kubot, Tsu, Mie, Japan
TEL	+81592322531
Email	eosinophilosophy@gmail.com

Public contact
Name of contact person	Mizuho Nagao
Organization	Mie National Hospital
Division name	Institute for Clinical Research
Address	357 Osato-kubot, Tsu, Mie, Japan
TEL	+81592322531
Homepage URL
Email	nagaomizuho@mie-m.hosp.go.jp

Sponsor
Institute	Mie National Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labore and Welfar, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	University of Chiba
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	国立病院機構三重病院、千葉大学病院、獨協医大病院、国立病院機構下志津病院、群馬大学病院、千葉県子ども病院、あいち小児保健医療総合センター、大阪府立呼吸器アレルギー医療センター、国立病院機構福山医療センター、富山大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 20 Day
Anticipated trial start date	2015 Year 01 Month 06 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

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

Management information
Registered date	2015 Year 01 Month 05 Day
Last modified on	2016 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018717