Unique ID issued by UMIN | UMIN000024729 |
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Receipt number | 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 16:31:13 |
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
Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy
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
Effect of adjunctive TGF-rich food in oral immunotherapy for milk allergy
Japan |
food allergy (milk)
Clinical immunology |
Others
NO
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
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Proportion of the subjects who tolerate more than 25 ml of milk (cumulative dose) at oral milk challenge after the treatment for 1 year
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
NO
Central registration
2
Treatment
Food |
Milk-derived TGF-beta-enriched food
Oral immunotherapy with milk
3 | years-old | <= |
15 | years-old | >= |
Male and Female
Milk allergy patients definitively diagnosed by oral food challenge with threshold of more than 3ml, and 25 ml or less.
1) patients who are on other immunotherapy
2)patients who have heart, liver and kidney diseases
3)patients with ncontrolled asthma or atopic dermatitis
40
1st name | |
Middle name | |
Last name | Takao Fujisawa |
National Hospital Organization Mie National Hospital
Allergy Center
357 Osato-kubota, Tsu, Mie, Japan
+81592322531
fujisawa@mie-m.hosp.go.jp
1st name | |
Middle name | |
Last name | Yu Kuwabara |
National Hospital Organization Mie National Hospital
Allergy Center
357 Osato-kubota, Tsu, Mie, Japan
+81592322531
yu_surrealist@hotmail.co.jp
National Hospital Organization Mie National Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
None
none
NO
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2016 | Year | 11 | Month | 14 | Day |
Unpublished
Open public recruiting
2016 | Year | 10 | Month | 12 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 11 | Month | 15 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 07 | Month | 31 | Day |
2023 | Year | 09 | Month | 30 | Day |
2023 | Year | 12 | Month | 31 | Day |
2016 | Year | 11 | Month | 06 | Day |
2019 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028442
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