NCT03476889Unknown不适用
A Randomised, Controlled, Double-blind, Parallel Group, Multi-country Study to Investigate the Safety and Tolerance of a Partly Fermented Infant Formula Containing Prebiotic Oligosaccharides in Healthy Term Infants
Nutricia Research2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2018年7月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Weight gain (infant formula comparison)
研究概览
简要总结
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.
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
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, singleton, term infants
- •Aged ≤14 days at randomisation/enrolment
- •Birth weight within normal range for gestational age and sex
- •Head circumference at birth within normal range for age and sex
- •Maternal age ≥18 years at birth;
- •Intervention arms: exclusively formula fed at randomisation (infants of mothers who autonomously chose not to breastfeed for any reason before their infant is ≤14 days of age, and who intend to exclusively formula feed until their infant is at least 17 weeks of age); OR Breastfed reference arm: exclusively breastfed at enrolment (infants of mothers who intend to exclusively breastfeed until their infant is at least 17 weeks of age);
- •Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years.
排除标准
- •Infants who require to be fed a special diet other than standard cow's milk based infant formula;
- •Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;
- •Infants known or suspected to have current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters, as per the clinical judgement of the Investigator;
- •Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters (including, but not limited to: GI malformations, congenital immunodeficiency), as per the clinical judgement of the Investigator;
- •Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;
- •Incapability of infants' parents/legally acceptable representatives to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parent(s)/legally acceptable representative(s) to comply with the protocol requirements;
- •Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication) as per Investigator's judgement.
- •Criteria for lactating mothers of subjects in the breastfed reference arm:
- •Lactating women who are currently participating or intend to participate in any other clinical study involving investigational products. Participation in purely observational studies is permitted;
- •Lactating women known to suffer from hepatitis B or human immunodeficiency virus;
- •Lactating women known to have any other significant medical condition(s) which might interfere with the study or its outcome parameters (breast abscess or mastitis which could interfere with lactation, or other clinically relevant infections, or consumption of medication/substances which could impact the infants' growth), as per the clinical judgement of the Investigator;
- •Lactating women who intend to feed their infants with a combination of human milk and infant formula.
研究组 & 干预措施
Intervention
Experimental
Cows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides
干预措施: Infant formula (Other)
Control
Active Comparator
Cows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra)
干预措施: Infant formula (Other)
Breastfed reference
No Intervention
Exclusively breastfed from birth to study completion
结局指标
主要结局
Weight gain (infant formula comparison)
时间窗: 17 weeks
Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product
次要结局
- Head circumference gain(17 weeks)
- Parent-reported GI Tolerance Parameters (daily diary)(17 weeks)
- Weight gain (human milk comparison)(17 weeks)
- Recumbent Length gain(17 weeks)
- Severity of treatment-related adverse events(17 weeks)
- Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale)(17 weeks)
- Incidence of treatment-related adverse events(17 weeks)
研究者
研究点 (2)
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