Amino Acid Feed Children's Study
An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
調査の概要
詳細な説明
Dietary management of Cows' Milk Allergy (CMA) involves avoiding cow's milk protein in the diet, whilst ensuring that an adequate nutritional intake is achieved with suitable alternative foods or prescribable feeds. A number of studies and clinical insights indicate that CMA is persisting longer than infancy, into later childhood and becoming more complex. If a child has CMA, eliminating the offending allergens whilst maintaining an intake of food that meets their nutritional requirements for growth and development is challenging due to the significant nutritional contribution these foods make to a child's diet, particularly milk and dairy products. This supports the need for alternatives to cow's milk to be available for children >1year of age to help meet their nutritional needs. Aminoacid based feeds are already widely used in clinical practice to meet this need. A new nutritionally complete amino acid based powdered feed for the dietary management of CMA, or other conditions where an amino acid based is recommended, in children aged 1-10yrs old, has been developed.
This study is to support the use of this new amino acid based feed in clinical practice. The study will evaluate the tolerance and acceptability of the amino acid based powdered feed in 20 children aged 1-10yrs of age receiving or requiring an amino acid based feed for the dietary management of CMA and food allergy associated conditions, over 4 weeks. The primary outcome will be gastrointestinal tolerance, with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Male or female
- Age 1-10 years
- Currently using or requiring an amino acid based feed
- Expected to receive at least 30% of their energy intake from the study product
- Written informed consent from parents / carer
Exclusion Criteria:
- Parenteral nutrition contributing more than 70% of total energy intake
- Children with major hepatic or renal dysfunction
- Participation in other studies within 2 weeks prior to entry of this study
- Investigator concern around willingness/ability of parent/carer to comply with protocol requirements
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Amino Acid Feed
An amino acid based multi-nutrient powdered feed
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Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days).
The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management.
The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.
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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 |
|---|---|---|
|
Gastro intestinal tolerance questionnaire
時間枠：4 weeks
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Gastro-intestinal tolerance will be recorded at baseline and on days 1, 2, 3 and 7 of week 1 of the study.
During weeks 2 and 3 tolerance will be recorded once at the end of each week on days 14 and 21.
During week 4, tolerance will be recorded on days 26, 27 and 28.
Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
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4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance with feed prescription (amount prescribed versus consumed)
時間枠：4 weeks
|
Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the parents/carer.
The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted
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4 weeks
|
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Product acceptability questionnaire
時間枠：4 weeks
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Feed acceptability (ease of use) will be assessed at the end of week 4 by questionnaire completed by the parents/carer.
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4 weeks
|
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Nutrient intake (energy, protein and micronutrients)
時間枠：4 weeks
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Nutrient intake, including the intake of all nutrition provided (including the study product, any parenteral feeding, other enteral tube feeding, foods, drinks etc) will be recorded at baseline and on Day 28 by the Dietitian using 24hour recall, and then in 3 day food diaries at baseline (Days 1, 2 and 3) and Week 4 (Days 26, 27 and 28) by the parent/carer.
A dietary analysis program will be used to calculate total dietary intake
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4 weeks
|
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Weight (kg)
時間枠：4 weeks
|
For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing.
Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm.
For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
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4 weeks
|
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Height (cm)
時間枠：4 weeks
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For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing.
Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm.
For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
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4 weeks
|
|
Head circumference (cm)
時間枠：4 weeks
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For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing.
Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm.
For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
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4 weeks
|
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Safety by Adverse Event reporting
時間枠：4 weeks
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All adverse events will be recorded, throughout the study.
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4 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。
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