NCT01017991终止不适用
Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
Société des Produits Nestlé (SPN)18 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 18
- 主要终点
- daily total crying time
研究概览
简要总结
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •full term infants greater than or equal to 37 wks gestation
- •3 weeks to less than or equal to 4 months of age upon enrollment
- •experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
- •otherwise healthy as reported by parent/caregiver
- •is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
- •taking no more than one feeding of breast milk per day
- •having not initiated weaning foods or beverages other than infant formula or breast milk
- •study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
- •informed consent signed(parent/legal representative)
排除标准
- •Chromosomal or major congenital anomalies
- •known cow's milk allergy
- •receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
- •receiving an antibiotic or probiotic in the week prior to enrollment
- •complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
- •infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
- •infant currently participating in another conflicting clinical study
研究组 & 干预措施
Infant formula with probiotic
Experimental
Infant formula with probiotic for 0 to 12 months of age
干预措施: Milk based infant formula with probiotic (Other)
Standard infant formula
Placebo Comparator
Infant formula for 0 to 12 months of age
干预措施: Milk based infant formula (Other)
结局指标
主要结局
daily total crying time
时间窗: 28 days
次要结局
- Formula intake(4 days)
- Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies(4 days)
研究者
研究点 (18)
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