Unique ID issued by UMIN | UMIN000033254 |
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Receipt number | R000037913 |
Scientific Title | clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen |
Date of disclosure of the study information | 2018/07/07 |
Last modified on | 2023/07/08 18:05:14 |
clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen
oral immunotherapy with a very small amount of allergen
clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen
oral immunotherapy with a very small amount of allergen
Japan |
food allergy
Pediatrics |
Others
NO
It aims to establish oral immunotherapy which is safe and highly effective against food allergy.
Safety
Exploratory
Pragmatic
Not applicable
Number of cases that could cause release of the causative food to the remission level within 3 years from the start of oral immunotherapy
Compliance rate of protocol.
Blood test analysis in progress.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Food |
Egg:start dose = <0.2g
Milk:start dose = <0.2g
wheat:start dose = <0.2g
Others(e.g. peanuts, fish,)=<0.2g
Start ingestion and gradually increase. Continue for 3 years.
1 | years-old | <= |
15 | years-old | >= |
Male and Female
Children who have been diagnosed with food allergies and who are judged to be oral immunotherapy for allergy specialized outpatient clinics.
Specific serum IgE positive and obvious history of food allergy/oral food challenge test positive.
1.Patient with congenital disease such as chromosomal abnormalities.
2.Child with severe complication history (congenital heart disease, childhood blood tumor disease, surgical operation history).
3.Patient with bronchial asthma that applies to the control status "bad".
4.Contraindication example of administration of adrenaline intramuscular injection preparation
5.Other who judged that the research director is inappropriate as the research subject.
60
1st name | Toshiaki |
Middle name | |
Last name | Shimizu |
Juntendo University Graduate School of Medicine
Department of Pediatrics and Adolescent Medicine
113-8421
Bunkyo-ku,3-1-3
0338133111
tshimizu@juntendo.ac.jp
1st name | Susumu |
Middle name | |
Last name | Yamazaki |
Juntendo University Graduate School of Medicine
Department of Pediatrics and Adolescent Medicine
113-8421
Bunkyo-ku, 3-1-3
0338133111
susumu@juntendo.ac.jp
Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine
none
Other
JPN
Juntendo University Graduate School of Medicine
Bunkyo-ku, 3-1-3
0338133111
kenkyu5858@juntendo.ac.jp
NO
順天堂大学附属順天堂医院
2018 | Year | 07 | Month | 07 | Day |
Unpublished
Terminated
2018 | Year | 07 | Month | 01 | Day |
2018 | Year | 07 | Month | 01 | Day |
2018 | Year | 07 | Month | 01 | Day |
2023 | Year | 03 | Month | 01 | Day |
2023 | Year | 03 | Month | 30 | Day |
2023 | Year | 03 | Month | 30 | Day |
2023 | Year | 03 | Month | 30 | Day |
Since the intervation of "dietary guidance" and "oral immunotherapy" became ambiguous in the subjects included, we decided to stop the study and review it.
2018 | Year | 07 | Month | 03 | Day |
2023 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037913
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Research case data | |
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