NCT01861600已完成3 期
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas
研究概览
简要总结
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
详细描述
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, term (no less than 37 weeks, 0 days and no greater than 42 weeks, 0 days) singleton infants, between 7 days and 14 day post natal age
- •Weight for age ≥5th percentile according to Filipino growth tables/charts.
- •HM infants were exclusively consuming and tolerating HM
- •Mother must have made the decision to continue to exclusively breastfeed.
- •Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula
- •Parent/guardian must have previously made the decision to continue to exclusively formula feed
排除标准
- •Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa
- •Infants who are receiving any infant formula containing pro- or prebiotics
- •Family history of siblings with documented cow's milk protein intolerance/allergy
- •Conditions requiring infant feedings other than those specified in the protocol
- •Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation)
- •Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus)
- •Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases
- •Infants who have received any experimental treatment, participated in any other clinical trial, or received any other investigational intervention unrelated to this trial, prior to enrollment
- •Infants of any ancillary personnel connected with the study or the infants of first and second-degree relatives (parents, brothers, sisters, children, or grandchildren) of ancillary personnel
- •Presently receiving or have received any medication(s) which are known or suspected to affect fat digestion, absorption and/or metabolism (e.g., pancreatic enzymes), any vitamin and/or mineral supplements which contain calcium, all antibiotics and antifungal medications (except topical), suppositories, bismuth-containing medications, herbal supplements, or medications which may neutralize or suppress gastric acid secretion
- •HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum
结局指标
主要结局
Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas
时间窗: 8 weeks
stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents
次要结局
- Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas(8 weeks)
研究者
研究点 (2)
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