Unique ID issued by UMIN | UMIN000013769 |
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Receipt number | R000016073 |
Scientific Title | Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. |
Date of disclosure of the study information | 2014/04/21 |
Last modified on | 2021/10/05 10:22:11 |
Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Outpatient Oral Immunotherapy
Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Outpatient Oral Immunotherapy
Japan |
food allergy
Pediatrics |
Others
NO
To evaluate efficacy and safety of outpatient oral immunotherapy for food allergy focusing on target doses.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The purpose of this study is to clarify dose dependent outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient oral immunotherapy.
Patients are enrolled in two groups, which are divided by target amounts of OIT ingestion as 100% or 25% of maximum ingestion amount.
To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy.
To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children.
To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy.
Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent with its will for participation in advance.
The outcome at 2 years' follow up is analyzed in addition to that at 1 year.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
The target amount of ingestion, regarding tolerance acquisition, is defined one heated hen's egg, 100ml of cow's milk, and 100g of Japanese Udon noodles.
The maximum amount of ingestion at home is 100% amount of that in group A and 25% of that in group B, during one year oral immunotherapy.
3 | years-old | <= |
15 | years-old | >= |
Male and Female
Subjects, aged 3-15 years old, undergo oral food challenge within the 3 months before this trial.
They are confirmed mild or moderate positive objective symptoms caused by hen's egg, cow's milk, or wheat ingestion challenge.
The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a quarter of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 25ml, and that for wheat is more than 3g of Udon noodles and not greater than 25g of that.
The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg, 3ml of cow's milk, or 3g of Udon noodles by oral food challenge test.
The subject who is treated by adrenaline injection at oral food challenge test just before this study.
The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease.
The subject who is not appropriate for oral immunotherapy, judged by medical doctor.
100
1st name | |
Middle name | |
Last name | Motohiro Ebisawa |
National Hospital Organization Sagamihara National Hospital
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
042-742-8311
foodallergy@sagamihara-hosp.gr.jp
1st name | |
Middle name | |
Last name | Kiyotake Ogura |
National Hospital Organization Sagamihara National Hospital
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
042-742-7311
foodallergy@sagamihara-hosp.gr.jp
National Hospital Organization Sagamihara National Hospital
Research grant by the Ministry of Health, Labour and Welfare of Japan
Japan
NO
国立病院機構 相模原病院 小児科(神奈川県)
2014 | Year | 04 | Month | 21 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 18 | Day |
2014 | Year | 04 | Month | 21 | Day |
2017 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2014 | Year | 04 | Month | 21 | Day |
2021 | Year | 10 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016073
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