NCT01813175已完成不适用
Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 3
- 主要终点
- Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
研究概览
简要总结
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 43 Days 至 65 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
- •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 legal guardian's written informed consent
排除标准
- •Exclusion criteria for run-in period (visit 1, screening) are:
- •Being weaned before inclusion (introduction of any other foods other than formula or human milk)
- •Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
- •Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
- •Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
- •Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study
- •Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study
- •Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
研究组 & 干预措施
Intervention Group I
Active Comparator
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
干预措施: Regular non-hydrolysed cow's milk I (Other)
Interventional Group II
Active Comparator
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
干预措施: Regular non-hydrolysed cow's milk II (Other)
Control Group
Placebo Comparator
Regular non-hydrolysed cow's milk based infant formula
干预措施: Regular non-hydrolysed cow's milk - control (Other)
Reference Group
No Intervention
Exclusively breast-fed infants
结局指标
主要结局
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
时间窗: baseline, week 6
次要结局
- Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group(baseline, week 6)
- Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group(baseline, week 6)
研究者
研究点 (3)
Loading locations...
相似试验
撤回
2 期
Colonisation Resistance StudyHealthy InfantsNCT01507935Danone Asia Pacific Holdings Pte, Ltd.
已完成
不适用
To Investigate Effects of a New Infant Formula in Healthy Term Chinese InfantsHealthy InfantsNCT03520764Danone Nutricia284
已完成
不适用
Effect of Starter Formula on Infection PreventionGastro-intestinal InfectionsInfections With FeverNCT01880970Société des Produits Nestlé (SPN)477
已完成
不适用
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and SafetyHealthyNCT01609634Danone Asia Pacific Holdings Pte, Ltd.541
已完成
不适用
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified MilkFormula Feeding of Healthy Full Term InfantsNCT01197365Heinz Italia SpA148