Unique ID issued by UMIN | UMIN000003943 |
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Receipt number | R000004740 |
Scientific Title | A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN |
Date of disclosure of the study information | 2010/07/23 |
Last modified on | 2017/01/09 16:14:02 |
A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
A randomized study in oral immunotherapy (OIT) for food allergy
A randomized study in oral immunotherapy for food allergy by Ministry of Health, Labour and Welfare in JAPAN
A randomized study in oral immunotherapy (OIT) for food allergy
Japan |
food allergy
Clinical immunology | Pediatrics |
Others
NO
The objectives of our study are to perform our rush oral immunotherapy (OIT) for children with severe food allergy, to evaluate the safety and efficacy of this method, and to analyze the mechanisms of desensitization and tolerance to food in this method.
Safety,Efficacy
A comparison of the dose response to double-blind, placebo-controlled food challenge (DBPCFC) before and after therapy between rush OIT group and elimination group. We will define the thresholds for clinically significant reactions in DBPCFC.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
2
Treatment
Food |
rush oral immunotherapy
allergen avoidance diet
5 | years-old | <= |
15 | years-old | >= |
Male and Female
1) children (ages 5-15 years).
2) patients with immediate allergic reactions to egg or milk.
3) egg: the threshold dose inducing allergic reactions <= 4 g.
milk: the threshold dose inducing allergic reactions <= 10 ml.
4) available to verbal communication and hospitalization.
1) patients who have been treated with rush oral immunotherapy.
2) patients with poorly controlled asthma or atopic dermatitis.
40
1st name | |
Middle name | |
Last name | Tsutomu Iwata |
Mie National Hospital
Institute for Clinical Research
357 Osatokubotatyo, Tsu-City , Mie, 514-0125 JAPAN
059-232-2531
iwped-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Naoka Itoh |
The University of Tokyo
Department of Pediatrics
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 JAPAN
03-3815-5411
naoka_i@hotmail.com
Mie National Hospital
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
国立病院機構 三重病院(三重県)
千葉大学医学部附属病院(千葉県)
千葉県こども病院(千葉県)
国立病院機構 下志津病院(千葉県)
群馬大学医学部附属病院(群馬県)
獨協医科大学病院(栃木県)
富山大学附属病院(富山県)
大阪府立呼吸器アレルギー医療センター(大阪府)
あいち小児保健医療総合センター (愛知県)
2010 | Year | 07 | Month | 23 | Day |
Unpublished
No longer recruiting
2010 | Year | 07 | Month | 23 | Day |
2010 | Year | 07 | Month | 26 | Day |
2010 | Year | 07 | Month | 23 | Day |
2017 | Year | 01 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004740
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