Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Gut microbiota composition and its metabolic activity
研究概览
简要总结
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
- •Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
- •Parents' or guardian's written informed consent
排除标准
- •Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
- •Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
- •Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
- •Significant congenital abnormality that could affect the study results
- •Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •Gastroenteritis in the last two weeks before inclusion
研究组 & 干预措施
Intervention Group I
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I
干预措施: Regular non-hydrolysed cow's milk (Other)
Intervention Group II
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II
干预措施: Regular non-hydrolysed cow's milk (Other)
Control Group
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
干预措施: Regular non-hydrolysed cow's milk (Other)
Reference group
Exclusively breast-fed infants
结局指标
主要结局
Gut microbiota composition and its metabolic activity
时间窗: Week 6
* Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut * Metabolic activity of the gut microbiota: pH, SCFA, lactate
次要结局
- Number, type and severity of (serious) adverse events(Week 1, Week 3, Week 6, Week 8)
- Gastrointestinal symptoms (incidence and severity)(Week 1, Week 3, Week 6, Week 8)
- Anthropometry(Week 1, Week 3, Week 6, Week 8)