Unique ID issued by UMIN | UMIN000040531 |
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Receipt number | R000046267 |
Scientific Title | Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts). |
Date of disclosure of the study information | 2020/05/26 |
Last modified on | 2020/11/26 16:26:01 |
Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).
Low-dose oral immunotherapy
Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).
Low-dose oral immunotherapy
Japan |
food allergy
Pediatrics |
Others
NO
To evaluate the efficacy and safety of low-dose oral immunotherapy for food allergies.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The rate of short-term unresponsiveness* to the middle-dose** after 1 year
* Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks."
** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."
1. Frequency of adverse reactions
2. The rate of short-term unresponsiveness* to the middle-dose** after 2 years, 3 years, 4 years, and 5 years from the start of oral immunotherapy(OIT)
3. Changes of specific IgE, IgG, and IgG4
* Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks."
** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Food |
1.The target amount of ingestion is defined as 2 g buckwheat noodle, 10 g fruits, and 0.5 g walnuts, cashews, hazelnuts, and macadamia nuts.
2.The subjects are asked to take a small amount of their causative food at the inpatient department. The amount is gradually built up to their target amount depending on their symptoms.
3.The subjects continue to ingest their causative foods for a year after discharge from the hospital.
1 | years-old | <= |
18 | years-old | >= |
Male and Female
Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 2 g buckwheat noodle (100 mg buckwheat protein), 5 g fruits, 0.5 g walnuts (75 mg walnut protein), 0.5 g cashews (90 mg cashew protein), 0.5 g hazelnuts (75 mg hazelnut protein), and 0.5 g macadamia nuts (45 mg macadamia nut protein).
Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.).
1.The subject who has poorly treated atopic dermatitis and bronchial asthma.
2.The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.
30
1st name | Motohiro |
Middle name | |
Last name | Ebisawa |
National Hospital Organization Sagamihara National Hospital
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
252-0392
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
042-742-8311
mebisawa@foodallergy.jp
1st name | Noriyuki |
Middle name | |
Last name | Yanagida |
National Hospital Organization Sagamihara National Hospital
Clinical Research Center for Allergy and Rheumatology
252-0392
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
042-742-8311
yana@foodallergy.jp
National Hospital Organization Sagamihara National Hospital
Self funding
Self funding
National Hospital Organization Sagamihara National Hospital
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
042-742-8311
222-rinri@mail.hosp.go.jp
NO
2020 | Year | 05 | Month | 26 | Day |
Unpublished
Open public recruiting
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 11 | Month | 17 | Day |
2015 | Year | 11 | Month | 17 | Day |
2025 | Year | 03 | Month | 31 | Day |
2020 | Year | 05 | Month | 26 | Day |
2020 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046267
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