Diet and Behavior in Young Children With Autism
調査の概要
詳細な説明
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy.
Children in this study will be following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester Medical Center
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参加基準
適格基準
就学可能な年齢
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:
- Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive.
- Participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home
- A score higher than 30 on the Mullen Early Learning scale
- Ability to maintain a gluten- and casein-free diet during the study
- In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Participants will follow a gluten-free and casein-free diet for 18 weeks.
The compliance with the diet was monitored with 24 hour dietary recall and nutritional sufficiency with diet diary analysis.
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Participants will follow a gluten-free and casein-free diet for 18 weeks.
All children received individual EIBI interventions to decrease the confound of different types of therapies.
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アクティブコンパレータ：2
After established on a gluten free and casein free diet for at least 6 weeks, participants received double blind, placebo controlled challenges containing gluten, casein, gluten+casein, or placebo in a random order.
Data was collected on behavioral and physiologic responses relative to the challenges.
Children remained on the gluten free and casein free diet throughout this period.
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Participants will follow a gluten-free and casein-free diet for 18 weeks.
They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response.
They remain on the gluten free and casein free diet for the entire study period.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Safety and efficacy of the gluten free casein free diet
時間枠：Measured at Weeks 6,18 and 30
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Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
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Measured at Weeks 6,18 and 30
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan Hyman, MD、University of Rochester
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- U54MH066397 (米国 NIH グラント/契約)
- DDTR BD-DD
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。