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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024729
Receipt No. R000028442
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
Date of disclosure of the study information 2016/11/14
Last modified on 2019/05/13

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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 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
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
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/ctr_e/ctr_view.cgi?recptno=R000028442

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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