基本情報/Basic information |
一般向け試験名/Public title |
鶏卵,牛乳,小麦アレルギー児に対する外来経口免疫療法(多施設共同研究) |
Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. |
一般向け試験名略称/Acronym |
多施設外来経口免疫療法 |
Multicenter Outpatient Oral Immunotherapy
(MO-OIT) |
科学的試験名/Scientific Title |
鶏卵,牛乳,小麦アレルギー児に対する外来経口免疫療法(多施設共同研究) |
Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. |
科学的試験名略称/Scientific Title:Acronym |
多施設外来経口免疫療法 |
Multicenter Outpatient Oral Immunotherapy
(MO-OIT) |
試験実施地域/Region |
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評価/Assessment |
主要アウトカム評価項目/Primary outcomes |
・OIT目標摂取量を100%群と25%群の2群に設定し,外来経口免疫療法の耐性獲得率や症状誘発率に関する摂取量と治療成績の関連性を明らかにする。 |
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. |
副次アウトカム評価項目/Key secondary outcomes |
・無介入群を対照として比較した場合の,OIT治療の有効性を検証する。
・中等症以下の食物アレルギー児に対して外来OITが安全に実施できることを,多施設共同研究で検証する。
・OIT群を重症度で層別化し,各層の治療反応性を解析する。
・1年後の時点で耐性を獲得しなかった症例に関して、事前に同意を得た施設で、希望された患者を対象に治療を継続し、2年後時点での治療成績を追加で解析する。 |
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, performed by multicenter trial.
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 at each hospital with its will for participation in advance.
The outcome at 2 years' follow up is analyzed in addition to that at 1 year.
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介入/Intervention |
群数/No. of arms |
2 |
介入の目的/Purpose of intervention |
治療・ケア/Treatment |
介入の種類/Type of intervention |
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介入1/Interventions/Control_1 |
・耐性化目標量を,加熱全卵1個,牛乳100ml,うどん100gに設定する。 |
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. |
介入2/Interventions/Control_2 |
A群は100%量,B群はA群の25%量を最大目標として、1年間のOITを実施する。 |
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. |
介入3/Interventions/Control_3 |
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介入4/Interventions/Control_4 |
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介入5/Interventions/Control_5 |
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介入6/Interventions/Control_6 |
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介入7/Interventions/Control_7 |
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介入8/Interventions/Control_8 |
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介入9/Interventions/Control_9 |
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介入10/Interventions/Control_10 |
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適格性/Eligibility |
年齢(下限)/Age-lower limit |
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年齢(上限)/Age-upper limit |
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性別/Gender |
男女両方/Male and Female |
選択基準/Key inclusion criteria |
・3ヶ月以内に食物負荷試験を実施し,中等症以下の明らかな陽性症状を呈した3歳以上15歳以下の鶏卵,牛乳,または小麦アレルギーの児。
・食物負荷試験での症状誘発域値(x)が,鶏卵1/32個<x≦1/4個,牛乳3ml<x≦25ml,または小麦;うどん3g<x≦25gの児。 |
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. |
除外基準/Key exclusion criteria |
・食物負荷試験で,加熱全卵1/32個,牛乳3ml,またはうどん3g以下の閾値で明らかな陽性症状を呈した場合。
・食物負荷試験で,症状誘発閾値によらずアドレナリンを使用した場合。
・基礎疾患やアトピー性皮膚炎や気管支喘息の管理不良例。
・その他,医師が不適当と判断した例。 |
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. |
目標参加者数/Target sample size |
90 |
責任研究者/Research contact person |
責任研究者/Name of lead principal investigator |
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名 |
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ミドルネーム |
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姓 |
Motohiro Ebisawa |
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所属組織/Organization |
国立病院機構相模原病院 |
National Hospital Organization Sagamihara National Hospital |
所属部署/Division name |
臨床研究センター アレルギー性疾患研究部 |
Department of Allergy, Clinical Research Center for Allergy and Rheumatology |
郵便番号/Zip code |
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住所/Address |
252-0392神奈川県相模原市南区桜台18-1 国立相模原病院 臨床研究センター アレルギー性疾患研究室 |
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392. |
電話/TEL |
042-742-8311 |
Email/Email |
foodallergy@sagamihara-hosp.gr.jp |
試験問い合わせ窓口/Public contact |
試験問い合わせ窓口担当者/Name of contact person |
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名 |
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ミドルネーム |
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姓 |
Kiyotake Ogura |
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組織名/Organization |
国立病院機構相模原病院 |
National Hospital Organization Sagamihara National Hospital |
部署名/Division name |
臨床研究センター アレルギー性疾患研究部 |
Department of Allergy, Clinical Research Center for Allergy and Rheumatology |
郵便番号/Zip code |
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住所/Address |
252-0392神奈川県相模原市南区桜台18-1 国立相模原病院 臨床研究センター アレルギー性疾患研究室 |
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392. |
電話/TEL |
042-742-7311 |
試験のホームページURL/Homepage URL |
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Email/Email |
foodallergy@sagamihara-hosp.gr.jp |