Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses
Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial
調査の概要
詳細な説明
One of the most important early influences on the immune system is the intestinal microflora. The gastrointestinal tract, being the largest body area interacting with the environment, is one of the earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. Probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. This is extremely important as allergic diseases are on the rise worldwide. Probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse.
This double-blind, randomized placebo-controlled study has recruited 253 children from birth. These babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. Children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. Blood samples will be collected at birth (cord blood) and at 1 year of age. Blood will be analyzed for cytokines, total IgE and specific IgE. Skin prick test for common allergens will also be performed at 1 year of age. Stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Singapore、シンガポール、119074
- National University Hospital (NUH)
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Parents agree to the subject's participation in the study and informed consent has been obtained.
- Either parent or sibling (i.e. first degree relative) has a history of atopy. This will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema and a positive skin prick test to any of a panel of common allergens.
- The subject is born at above 35 weeks of gestation and weighs above 2 kg.
- The subject does not have major congenital malformations/major illness.
- Family appears to be able to successfully complete this trial.
Exclusion Criteria:
- Mother has a medical illness, which in the opinion of the investigator, will interfere with the results of the study.
- The parent is unable/unwilling to comply with procedures.
- The parents choose to totally breast-feed the child.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:プラセボ
プロバイオティクスを添加していない市販の牛乳ベースの乳児用調製粉乳
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プロバイオティクスを添加していない市販の牛乳ベースの乳児用調製粉乳
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実験的:Probiotics
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
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Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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Atopic eczema by 2 years of age
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二次結果の測定
結果測定 |
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Asthma by 2 years of age
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Allergic Rhinitis by 2 years of age
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Allergen sensitization by 2 years of age
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協力者と研究者
捜査官
- 主任研究者:Dr Lynette Shek, Consultant、National University Hospital (NUH), Singapore
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。