An Evaluation of the Tolerance and Acceptability of a Whey-based Extensively Hydrolysed Feed With Pre- and Probiotics, for the Dietary Management of Cows' Milk Allergy in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
研究概览
简要总结
This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged <13 months
- •Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
- •Expected to receive at least 25% of their energy intake from the study feed
- •Already fed with infant formula or hypoallergenic formula (either partially or fully)
- •Written, informed consent from parent/carer
排除标准
- •"Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
- •Exclusively breastfed infants
- •Primary lactose intolerance
- •History of poor tolerance to whey based EHFs
- •Immunocompromised infants
- •Premature infants (born <37 weeks)
- •Major hepatic or renal dysfunction
- •Requirement for any parenteral nutrition
- •Tube-fed via a post-pyloric route
- •Participation in other clinical intervention studies within 1 month of recruitment to this study
- •Investigator concern around the ability of family to comply with protocol and requirements of study
结局指标
主要结局
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
时间窗: 31 days
Gastro-intestinal tolerance will be recorded by the parent on Baseline Days 1-3 (where this period is undertaken by the patient) and on Intervention Days 1, 2, 3, 7, 14, 21, 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
- Nutrient intake(31 days)
- Parent-reported Atopic Symptoms(31 days)
- Food Allergy QOL - Parental burden questionnaire(31 days)
- Atopic dermatitis severity(31 days)
- Change in weight(31 days)
- Safety (Adverse Events)(31 days)
- Change in length (cm)(31 days)
- Formula acceptability: Likert-style questionnaire(31 days)
- Compliance(31 days)
- Change in head circumference (cm)(31 days)