A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Daily inconsolable crying time using data recorded on subject's diaries
研究概览
简要总结
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
详细描述
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic.
The various time points of the outcome are:
V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 21 Days 至 56 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 21-56 days (both inclusive);
- •Gestation age 37-42 weeks;
- •Normal birth weight for gestational age and gender
- •5-minute APGAR score >7;
- •Diagnosed with infantile colic ;
- •Fully formula fed for at least 7 days before randomisation;
- •Written informed consent from the parent and/or legal representative.
排除标准
- •Any plausible cause of inconsolable crying as judged by the investigator;
- •Presence of non-functional vomiting or failure to thrive;
- •Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition;
- •Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes;
- •Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations;
- •Received any special formula (e.g. lactose-free, hydrolysed protein);
- •Received any of the following products/medication within 7 days before randomisation:
- •Systemic antibiotics
- •Prokinetics
- •Proton pump inhibitors
- •Twins or triplets or other infant(s) <6 months of age living in the same household;
- •Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
- •Current participation in another clinical study involving investigational or marketed products.
研究组 & 干预措施
Intervention group
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
干预措施: Specific hydrolysed proteins (Other)
Control group
Standard cow's milk with prebiotics mixture
干预措施: Standard cow's milk with prebiotics mixture (Other)
结局指标
主要结局
Daily inconsolable crying time using data recorded on subject's diaries
时间窗: 6 weeks
Daily inconsolable crying time over 6 weeks
次要结局
- Daily stool consistency using data recorded on subject's diaries(6 weeks)
- Daily inconsolable fussing time using data recorded on subject's diaries(6 weeks)
- Daily stool frequency using data recorded on subject's diaries(6 weeks)
- Daily crying time using data recorded on subject's diaries(6 weeks)
- Daily fussing time using data recorded on subject's diaries(6 weeks)
- The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire(6 weeks)
- The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire(6 weeks)