Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Gastrointestinal symptoms as determined by CoMiSS
研究概览
简要总结
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
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
- 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
- •Age between 14 days and 90 days.
- •Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.
- •Infants who have received CMF for at least 7 consecutive days.
- •Exclusive formula feeding.
- •Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and <
- •Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol
排除标准
- •Exclusively or partially feeding with human milk
- •Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement
- •Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters.
- •Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance.
- •Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication)
- •Sibling already participating in this study
- •Participation in another clinical trial
结局指标
主要结局
Gastrointestinal symptoms as determined by CoMiSS
时间窗: Difference between groups at Day 14 of the intervention
The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms).
Gastrointestinal tolerance as determined by IGSQ
时间窗: Difference between groups at the end of the intervention at 24 weeks
The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress.
次要结局
- Gastrointestinal symptoms throughout the study as determined by CoMiSS(From enrollment to the end of the intervention at 24 weeks)
- Gastrointestinal tolerance throughout the study as determined by IGSQ(From enrollment to the end of the intervention at 24 weeks)
- Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari(From enrollment to the end of the intervention at 24 weeks)
- Occurrence, duration and severity of respiratory infections as determined by CARIFS(From enrollment to the end of the intervention at 24 weeks)
- Occurrence, duration and severity of ear infections as determined by AOM-SOS V5(From enrollment to the end of the intervention at 24 weeks)
- Quality of life as determined by PedsQL(From enrollment to the end of the intervention at 24 weeks)
- Quality of life as determined by WHOQoL-BREF(From enrollment to the end of the intervention at 24 weeks)
- Weight(From enrollment to the end of the intervention at 24 weeks)
- Height(From enrollment to the end of the intervention at 24 weeks)
- Head circumference(From enrollment to the end of the intervention at 24 weeks)
- WHO z-scores(From enrollment to the end of the intervention at 24 weeks)
- Fecal parameters(Baseline, Day 14, Day 28, Week 12 and Week 24)
- Sleep and Crying episodes(Baseline, Day 14, Day 28, Week 12 and Week 24)
- Stool frequency & consistenty(Baseline, Day 14, Day 28, Week 12 and Week 24)