NCT02031003已完成不适用
Effect of an Infant Formula With High 2-Palmitic Vegetable Oil or an Identical Formula Supplemented With Oligofructose on Stool Composition and Stool Characteristics in Healthy Term Infants in Taiwan
Société des Produits Nestlé (SPN)4 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2010年9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
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Stool Composition
研究概览
简要总结
- The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber.
- The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).
- The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups.
- The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.
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
- 25 Days 至 45 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry.
- •Human milk fed infants were exclusively consuming and tolerating HM and the 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 and parents/LAR must have previously made the decision to continue to exclusively formula feed.
排除标准
- •Infants receiving any amount of supplemental HM with infant formula feeding or vice versa
- •Family history of siblings with documented cow's milk protein intolerance/allergy
- •Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases
研究组 & 干预措施
Human Milk (HM)
No Intervention
Non-randomized Human Milk group
Control
Other
Standard infant formula
干预措施: Infant formula (Dietary Supplement)
Experimental 1
Experimental
Standard infant formula containing a new fat blend
干预措施: Infant formula (Dietary Supplement)
结局指标
主要结局
Stool Composition
时间窗: Day 28
Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents
次要结局
- Stool Consistency determined using a 3-day stool diary(Days 14 and 28)
- Stool frequency determined using a 3-day stool diary(Day 14 and 28)
- Incidence of adverse events(From ICF signing until 14 days after last study feeding)
- Urine pH(Baseline and Day 28)
- GI Tolerance(Baseline, Day 14 and Day 28)
- Urine osmolality(Baseline and Day 28)
- Anthropometric measurements(Baseline, Day 14 and Day 28)
- Anthropometric measurements (z-scores)(Baseline, Day 14 and Day 28)
研究者
研究点 (4)
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