UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016114 |
|---|---|
| Receipt number | 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 22:09:06 |
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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
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
nagaomizuho@mie-m.hosp.go.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018717
