An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Gastro intestinal tolerance questionnaire
研究概览
简要总结
This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated conditions, over 4 weeks.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Amino Acid Feed
An amino acid based multi-nutrient powdered feed
干预措施: Amino Acid Feed (Dietary Supplement)
结局指标
主要结局
Gastro intestinal tolerance questionnaire
时间窗: 4 weeks
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
次要结局
- Head circumference (cm)(4 weeks)
- Safety by Adverse Event reporting(4 weeks)
- Nutrient intake (energy, protein and micronutrients)(4 weeks)
- Compliance with feed prescription (amount prescribed versus consumed)(4 weeks)
- Product acceptability questionnaire(4 weeks)
- Weight (kg)(4 weeks)
- Height (cm)(4 weeks)