Unique ID issued by UMIN | UMIN000013374 |
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Receipt number | R000015599 |
Scientific Title | Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients |
Date of disclosure of the study information | 2014/03/08 |
Last modified on | 2019/03/12 12:21:00 |
Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
oral immunotherapy with hypoallergenic formula
Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
oral immunotherapy with hypoallergenic formula
Japan |
severe milk allergy
Pediatrics |
Others
NO
To evaluate efficacy and safety of oral immunotherapy with hypoallergenic formula for severe milk allergic children.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
The improvement of tolerance to milk of children in each study group
Milk specific-IgE, peripheral basophil activation against milk, milk specific-T cell activation
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
drink extensively hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
1 | years-old | < |
20 | years-old | >= |
Male and Female
Eligible participants were aged 1-20 years with an immediate hypersensitivity reaction after small amount of milk ingestion.
Use of antihistamines within three days prior to double blind placebo controlled food challenge (DBPCFC)
Uncontrolled bronchial asthma.
judged inappropriate for this study by doctor
30
1st name | Urisu |
Middle name | |
Last name | Atsuo |
Fujita Health University, Banbuntane Hotokukai Hospital
Department of Pediatrics
454-0012
3-6-10 Otobashi, Nakagawa Ward, Nagoya Aichi.Japan
052-323-5649
urisu@fujita-hu.ac.jp
1st name | Chisato |
Middle name | |
Last name | Inuo |
Fujita Health University
Department of Pediatrics
470-1192
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
0562-93-2469
http://www.fujita-hu.ac.jp/~pedia/pg146.html
inuo@mbh.nifty.com
Fujita Health University
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
IRB of Fujita Health University
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
0562-93-2139
f-irb@fujita-hu.ac.jp
NO
藤田保健衛生大学
2014 | Year | 03 | Month | 08 | Day |
Unpublished
No longer recruiting
2012 | Year | 11 | Month | 08 | Day |
2013 | Year | 02 | Month | 08 | Day |
2015 | Year | 06 | Month | 02 | Day |
2015 | Year | 06 | Month | 02 | Day |
2015 | Year | 06 | Month | 02 | Day |
2018 | Year | 04 | Month | 01 | Day |
2014 | Year | 03 | Month | 08 | Day |
2019 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015599
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