Amino Acid Feed Children's Study
An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gastro intestinal tolerance questionnaire
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Compliance with feed prescription (amount prescribed versus consumed)
기간: 4 weeks
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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
기간: 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)
기간: 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)
기간: 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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Height (cm)
기간: 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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Head circumference (cm)
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Amino Acid Feed에 대한 임상 시험
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Florida International UniversityAcademy of Nutrition and Dietetics완전한
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Galmed Pharmaceuticals Ltd완전한
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University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)모병
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...완전한