A Prospective, Randomized, DB Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 43
- 主要终点
- The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.
研究概览
简要总结
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA.
This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.
详细描述
Infants who qualify will begin a 7-day milk protein elimination diet that excludes all milk or products which contain milk. Parents will be asked to keep a food diary of everything the child eats during the week following the Screening Visit. During this week, the child can continue to drink their current hypoallergenic formula.
Subjects will be assessed at seven study visits at baseline, two weeks, four weeks and then monthly until the end of the study period, where the following will be assessed:
Study Visit 1 (Day -7): Baseline
This will be carried out at entry to the trial to collect baseline data; at this visit subjects will under go the following assessments:
Assess Patient suitability Obtain Informed Consent Obtain Subject number Perform physical exam and clinical assessment Medical history and assessment including SCORing Atopic Dermatitis assessment (SCORAD) Obtain weight, length and head circumference Collect a 9ml venous blood sample The following is to analysed by the central lab; Plasma total protein/albumin and prealbumin Blood urea nitrogen, electrolytes and creatinine Complete blood count with differential Alkaline phosphatase. Serum Iron, Total Iron Binding Capacity and Ferritin Plasma fatty acid analysis Provide stool lab kits and explain to parent/caregiver how to collect stool sample during the pre-evaluation week Provide one-week subject diary (Subject Diary 1) and instruct parent/caregiver on how to complete record, clinical symptoms and stool characteristics (frequency, consistency and color) in subject diary.
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
- 1 Day 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
- •Positive double-blind placebo controlled food challenge with cow milk
- •A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
- •Confirmed history of a reaction to cow milk protein with CM-specific IgE of >15kU/L for children over two years and > 5kU/L for children under two years.
- •Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
- •No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
- •For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
- •Written informed consent / ability to give informed consent.
- •These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,
排除标准
- •All subjects
- •Infants <5lb 8oz at birth
- •Infants < 37 weeks gestation
- •Infants with severe concurrent illness or major congenital malformations
- •Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
- •Unable to adhere to protocol instructions due to non compliance of parent or caregiver
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
- •An infant of any personnel connected with the study
- •Infants whose parent/caregiver is younger than the legal age of consent
- •For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
- •These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.
结局指标
主要结局
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.
时间窗: 4 months
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. Length and head circumference measures will also be collected and analysed. Both the growth velocities of the group as a whole (cross-sectional group data) and individuals (longitudinal individual data) will be reviewed and analysed. In assessing group data, comparisons of increments per unit of time will be made. Due to the varying ages of the subjects recruited to the study, growth measures will be concerted to z-scores using an appropriate reference population to allow a meaningful comparison of the ability of the formulas to promote growth. In assessing the growth of individual infants, data will be plotted on National Centre for Health Statistics (NCHS) growth charts and assessed qualitatively.
次要结局
未报告次要终点