Unique ID issued by UMIN | UMIN000044897 |
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Receipt number | R000051280 |
Scientific Title | A randomized trial of ingestion methods after acquiring tolerance to medium doses with oral immunotherapy for patients with severe food allergy |
Date of disclosure of the study information | 2021/07/19 |
Last modified on | 2024/01/22 18:21:22 |
A randomized trial of ingestion methods after acquiring tolerance to medium doses with oral immunotherapy for patients with severe food allergy
A randomized trial of oral immunotherapy for children with severe food allergy after acquiring tolerance to medium doses
A randomized trial of ingestion methods after acquiring tolerance to medium doses with oral immunotherapy for patients with severe food allergy
A randomized trial of oral immunotherapy for children with severe food allergy after acquiring tolerance to medium doses
Japan |
food allergy
Pediatrics |
Others
NO
To clarify the appropriate method of OIT for patients with severe food allergy after achieving middle-dose tolerance ("continuation of middle-dose ingestion" vs "gradually increase ingestion-dose").
Low-dose was defined as "3 ml of cow's milk, or 2g of Udon (Japanese wheat noodles)".
Middle dose was defined as "25 ml of cow's milk, or 25g of Udon".
Safety,Efficacy
The rate of patients who were negative to oral food challenges with with 50 ml milk or 50 g udon after 1 year
Changes of specific IgE, IgG, IgG4
Frequency of adverse reactions
Rate of drop-out patients
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Food |
Gradual increase of ingestion dose
Continuing ingestion of middle doses.
5 | years-old | <= |
Not applicable |
Male and Female
Patients who acquired tolerance to a middle dose (25 ml of milk or 25 g of udon noodles) more than 1 year after low-dose OIT had been performed.
Decision of ineligibility by a physician
40
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
2021 | Year | 07 | Month | 19 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 03 | Month | 23 | Day |
2021 | Year | 04 | Month | 20 | Day |
2021 | Year | 07 | Month | 20 | Day |
2027 | Year | 03 | Month | 31 | Day |
2021 | Year | 07 | Month | 19 | Day |
2024 | Year | 01 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051280
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