UMIN-CTR Clinical Trial

Basic information
Public title	A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a oral immunotherapy for milk allergy
Acronym	Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy
Scientific Title	A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a oral immunotherapy for milk allergy
Scientific Title:Acronym	Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy
Region	Japan

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

Objectives
Narrative objectives1	Oral immunotherapy has been shown to have some efficacy in inducing desensitization for patients with severe unremitting food allergy. However, limitation has also been shown in terms of its side effects and difficulty in inducing tolerance. Safer and more effective therapy is needed. In this study, 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	Proportion of the subjects who tolerate more than 25 ml of milk (cumulative dose) at oral milk challenge after the treatment for 1 year
Key secondary outcomes	1.Safety: local reaction, systemic immediate-type allergic reaction and other 2.Days:reaching the maintenance dose 3.Prick test 4.Specific IgE and IgG4

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	3 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 more than 3ml, and 25 ml or less.
Key exclusion criteria	1) patients who are on other immunotherapy 2)patients who have heart, liver and kidney diseases 3)patients with ncontrolled asthma or atopic dermatitis
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takao Fujisawa
Organization	National Hospital Organization Mie National Hospital
Division name	Allergy Center
Zip code
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	+81592322531
Email	fujisawa@mie-m.hosp.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Yu Kuwabara
Organization	National Hospital Organization Mie National Hospital
Division name	Allergy Center
Zip code
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	+81592322531
Homepage URL
Email	yu_surrealist@hotmail.co.jp

Sponsor
Institute	National Hospital Organization Mie National Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

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、国立病院機構相模原病院、福井大学病院、群馬大学病院、獨協医大病院、千葉大学病院、、国立病院機構下志津病院、、千葉県子ども病院、富山大学病院、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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 14 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	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 12 Day
Date of IRB	2016 Year 09 Month 30 Day
Anticipated trial start date	2016 Year 11 Month 15 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 07 Month 31 Day
Date trial data considered complete	2023 Year 09 Month 30 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 06 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028442