A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Growth
研究概览
简要总结
This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 0 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 0-13 months
- •Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA
- •Will receive at least 30% of energy requirements from the study formula
- •Written informed consent from parent/carer
排除标准
- •Severe CMA (including anaphylaxis) and/or requiring an AAF
- •Faltering growth (based on NICE guidelines36 - Appendix 1)
- •Previous allergy to any study product ingredients (including whey hydrolysate and/or rice)
- •Primary lactose intolerance
- •Food Protein-Induced Enterocolitis Syndrome (FPIES)
- •Exclusively breast fed
- •Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes
- •Severe hepatic or renal insufficiency
- •Premature infants (born <37 weeks) with a corrected age of <4 weeks
- •Requirement for any parenteral nutrition
- •Participation in other clinical intervention studies within 1 month of recruitment
- •Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements
研究组 & 干预措施
Intervention
Hydrolysed rice protein formula
干预措施: Hydrolysed Rice Protein Formula (Other)
Control
Cow's milk based extensively hydrolysed formula
干预措施: Cow's Milk Based Extensively Hydrolysed Formula (Other)
结局指标
主要结局
Growth
时间窗: Baseline to three months
At Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) assessments, length and head circumference will be measured using standard measures to the nearest 0.1cm. Body weight (kg) will also be measured, where possible, by the investigating Dietitian/relevant HCP using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. These measures will be used to calculate z-scores (i.e., weight-for-length, weight, length, and head circumference; based on UK-WHO 2006 growth reference data for children 0-4 years old) and plotted on growth charts for centile measurement.
次要结局
- Patient Reported Atopic Symptoms(Baseline to three months)
- Cow's Milk Related Symptom Score(Baseline to three months)
- Dietetic Goal(Baseline to three months)
- Acceptability of the Study Formula(Baseline to three months)
- Food Allergy Quality of Life-Parental Burden (FAQL-PB)(Baseline to three months)
- Overall Safety(Through study completion, an average of three months)
- Gastrointestinal Tolerance(Baseline to three months)
- Stool frequency and consistency(Baseline to three months)
- Study Product Intake(Baseline to three months)
- Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)(Baseline to three months)
- Nutrient Intake (Energy, Protein, Micronutrients)(Baseline to three months)