Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 169
- 试验地点
- 18
- 主要终点
- daily total crying time
研究概览
简要总结
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
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
- 15 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants
- •Subjects appropriate for gestational age between 35 and 41 weeks
- •Subjects between 15-60 days old
- •Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
- •Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
- •Subjects exclusively bottle-fed at study entrance
- •Day care of the child only by mother/father
- •Provide written informed consent in accordance with legal requirement
排除标准
- •Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
- •Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
- •Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
- •Subjects receiving formula for special medical purposes
- •Exclusively breast-fed infants
- •Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
- •Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
- •Participation in any other clinical intervention
研究组 & 干预措施
control formula
infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
干预措施: control formula (Other)
intervention formula 1 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
干预措施: intervention formula 1 (Other)
intervention formula 2 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
干预措施: intervention formula 2 (Other)
结局指标
主要结局
daily total crying time
时间窗: 28 days
evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
次要结局
- formula intake(28 days)
- growth parameters(90 days)
- tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects(28 days)
- intestinal microbiota(0-28 days)