NCT01681355已完成不适用
Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian 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
- 50
- 试验地点
- 5
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks)
- •The mother had unequivocally decided not to exclusively breast-feed
- •Formula fed for at least one week, receiving at least two formula feedings per day
- •Birth weight appropriate for gestational age (AGA), 2500-4000g
- •Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
排除标准
- •Age > 17 weeks
- •Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement
- •Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start.
- •Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start.
- •Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia).
- •Infants with any history of or current participation in any other study involving investigational or marketed products.
- •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
Experimental
Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.
干预措施: Infant Formula (Other)
结局指标
主要结局
Gastrointestinal tolerance
时间窗: up to Week 6
Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
次要结局
未报告次要终点
研究者
研究点 (5)
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