Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Digestive tolerance
研究概览
简要总结
This is a prospective, open-label, single-arm study in a real-world setting of healthy Chinese toddlers provided with new toddler milk for a total of 4 weeks (28 days).
详细描述
The new toddler milk contains prebiotic and an optimized fat blend of bovine milk fat, vegetable fats, and a LC-PUFA oil mixture (providing DHA and ARA). The prebiotic and bovine milk fat-based blend have shown to be able to improve digestive comfort and milk taste. Physiological factors such as physical discomfort has been shown to be associated with negative emotionality and temperament (Putnam 2012). Therefore, the investigators hypothesize that by improving digestive comfort, they are able to influence child temperament, happiness, and other behavioral characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 33 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy toddlers born at term (37-42 weeks of gestation).
- •At enrolment visit, toddler age 12-33 months.
- •Birth weight ≥ 2500g and ≤ 4500g.
- •No known milk intolerance / allergies to cow's milk protein.
- •Habitually consuming some cow's milk or other traditional milks.
排除标准
- •Toddler is currently breastfed or is consuming breast milk.
- •Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67).
- •History of preterm birth
- •Currently experiencing severe constipation.
- •Currently diagnosed with other Functional Gastrointestinal Disorders.
- •Toddlers who have known cognitive and developmental disorders.
- •Toddlers who are currently participating in or have participated in another clinical trial within 4 weeks prior to trial start.
结局指标
主要结局
Digestive tolerance
时间窗: Baseline (week 0) and week 4 (Day 28±2)
Change in overall digestive tolerance composite scores measured by the Toddler Gut Comfort Questionnaire consisting of 10 questions on parent perceptions of constipation, diarrhea, gassiness, abdominal pain, bloating and other GI-related behaviors.
次要结局
- Temperament(from baseline (week 0) to week 4 (Day 28±2))
- Child's emotional expressions(at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).)
- Milk Satisfaction(at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).)
- Weight in kilograms(at week 0 (baseline) and week 4 (Day 28±2))
- Height in centimeters(at week 0 (baseline) and week 4 (Day 28±2))
- Milk intake(at baseline and prospectively during transition period (Day 1-3) and for three consecutive days on week 1 (Day 7±2), 2 (Day 14±2) and 4 (Day 28±2).)