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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016114
Receipt No. R000018717
Scientific Title 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
Date of disclosure of the study information 2015/01/06
Last modified on 2016/10/25

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Basic information
Public title 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
Acronym Effect of adjunctive TGF-rich food in rush 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 rush oral immunotherapy for milk allergy
Scientific Title:Acronym 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
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Allergy Center
Zip code
Address 357 Osato-kubot, Tsu, Mie, Japan
TEL +81592322531
Email eosinophilosophy@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mizuho Nagao
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code
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)

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、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

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 Terminated
Date of protocol fixation
2014 Year 08 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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