Unique ID issued by UMIN | UMIN000033345 |
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Receipt number | R000038014 |
Scientific Title | Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients |
Date of disclosure of the study information | 2018/07/10 |
Last modified on | 2020/07/10 13:28:15 |
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Japan |
Food allergy
Pediatrics |
Others
NO
To clarify the appropriate method of OIT for patients with severe food allergy after achieving low-dose desensitization ("continuation of low-dose ingestion" vs "gradually increase up to middle-dose").
Low-dose was defined as "one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut".
Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".
Safety,Efficacy
Sustained unresponsiveness to middle-dose after 12 months.
Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".
Changes of specific IgE, IgG, IgG4
Frequency of adverse reactions
The rate of sustained unresponsiveness to middle-dose after 5 years from start of OIT.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Food |
Oral immunotherapy with a target dose of middle-dose
Oral immunotherapy with ingestion of low-dose
5 | years-old | <= |
Not applicable |
Male and Female
Patients who performed low-dose oral immunotherapy (target dose of one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut) for 12 months or more.
Patients who achieved desensitization to low-dose and have been asymptomatic for 3 months or more.
Patients who failed middle-dose oral food challenge after 2 weeks of complete avoidance.
Decision of ineligibility by a physician
48
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, Sagamihara City, Kanagawa, Japan, 252-0392
042-742-8311
ssakura8010@foodallergy.jp
1st name | Ken-ichi |
Middle name | |
Last name | Nagakura |
National Hospital Organization Sagamihara National Hospital
Department of pediatrics
252-0392
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
042-742-8311
k.nagakura@foodallergy.jp
National Hospital Organization Sagamihara National Hospital
AMED (Japan Agency for Medical Research and Development)
Japanese Governmental office
Japan
National Hospital Organization Sagamihara National Hospital
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
042-742-8311
222-rinri@mail.hosp.go.jp
NO
国立病院機構相模原病院(神奈川県)
2018 | Year | 07 | Month | 10 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 07 | Month | 05 | Day |
2018 | Year | 06 | Month | 15 | Day |
2018 | Year | 07 | Month | 17 | Day |
2025 | Year | 03 | Month | 31 | Day |
2018 | Year | 07 | Month | 10 | Day |
2020 | Year | 07 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038014
Research Plan | |
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Registered date | File name |
2024/01/16 | 研究計画書.doc |
Research case data specifications | |
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Registered date | File name |
2024/01/16 | Case Data Specifications.docx |
Research case data | |
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Registered date | File name |
2024/01/16 | Case data.xlsx |