NCT05046418终止不适用
A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae with Synbiotics in Infants with Cow's Milk Allergy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Healthcare use
研究概览
简要总结
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.
详细描述
A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged <13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged <13 months
- •Confirmed or suspected CMA- based on healthcare professional (HCP) judgement
- •At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding
- •Recently prescribed a hypoallergenic formula containing synbiotics
排除标准
- •Exclusively breastfed infants
- •Primary lactose intolerance
- •Enterally fed infants
- •Premature infants (born <37 weeks) with a corrected age of less than 1 month
- •Infants with contraindications to the use of hyopallergenic formula containing synbiotics
- •Major hepatic or renal dysfunction
- •Investigator concern around the ability of family to comply with protocol and requirements of study
结局指标
主要结局
Healthcare use
时间窗: 6 months
Data on the changes in healthcare use will be collected from medical records
次要结局
- Clinical impact and acceptability(12 months post initiation of hypoallergenic formula containing synbiotics)
研究者
研究点 (1)
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