Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
研究概览
简要总结
In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.
详细描述
Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies.
In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants with a gestational age between 37 and 42 weeks.
- •Infants who have received cow's milk infant formula for at least 7 consecutive days.
- •Exclusive formula feeding.
- •Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and <10.
排除标准
- •exclusive or partial breastfeeding (or feeding human milk)
- •introduced to solid food/supplementary feeding
- •any congenital or chronic condition
- •previous or present gastrointestinal illness or malformation that could interfere with study parameters
- •diagnosed cow's milk allergy
- •receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
- •sibling already participating in this study, and/or participating in another clinical trial.
结局指标
主要结局
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
时间窗: 0 - 4 weeks
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
次要结局
- Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks(0 - 2 weeks)
- Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks(0 - 4 weeks)
- The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks(0 - 2 weeks)
- Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks(0 - 2 weeks)
- Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks(0 - 4 weeks)
- The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks(0 - 4 weeks)
- Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks(0 - 2 weeks)
- Adverse events(0 - 4 weeks)
- Anthropometric parameters after 2 weeks(0 - 2 weeks)
- Anthropometric parameters after 4 weeks(0 - 4 weeks)