Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Stool consistency
研究概览
简要总结
Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
详细描述
Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The data of the patients who fulfilled the following criteria are evaluated.
- •Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of > 2500grams who are either breastfed or formula fed.
- •Selection of the subgroup using oral nutrition
- •Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
- •Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
- •Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
排除标准
- •Infants with major congenital abnormalities will be excluded.
- •Infants with lack of data will also be excluded.
- •Infants, whose parents don't agree with informed consent, will be excluded.
结局指标
主要结局
Stool consistency
时间窗: 10 weeks
Amsterdam Infant Stool Scale
次要结局
- Bacteria Count(10 weeks)
研究者
Merih Cetinkaya
Associate Professor, MD,PhD
Kanuni Sultan Suleyman Training and Research Hospital