Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- number of gastrointestinal infections
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.
详细描述
An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial.
The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy term neonates
- •gestational age 37 to 42 weeks
- •birth weight 10th to 90th percentile (Voigt reference)
- •infants being exclusively formula-fed at enrollment
排除标准
- •infants with high risk of atopic disease due to family history
- •congenital disorder or syndrome with need for special diet / impairment of growth
- •antibiotic medication prior to enrollment
结局指标
主要结局
number of gastrointestinal infections
时间窗: within first year of life
次要结局
- number of infectious episodes (gastrointestinal, respiratory, fever episodes)(within first year of life)
- symptoms of food intolerance, constipation, colics(after 6 weeks, 12 weeks intervention)
- atopic manifestation(within 1st year of life)
- anthropometric parameters (gain in weight, length, head circumference)(after 6 weeks, after 12 weeks intervention)
- proportion of bifidobacteria on total stool bacteria(after 6 and 12 weeks intervention)
- stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)(after 6 weeks, 12 weeks intervention)
- calcium absorption(after 6 weeks, 12 weeks intervention)
- erythrocytes´ fatty acid profile(after 6 weeks intervention)
研究者
Antonia Nomayo, MD
MD
Waldkrankenhaus Protestant Hospital, Spandau