NCT03371615已完成不适用
A Randomised, Controlled, Double Blind Trial to Evaluate the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula Containing Prebiotics and Locust Bean Gum in Infants With Regurgitation.
Nutricia Research2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年11月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- GI tolerance
研究概览
简要总结
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 13 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton healthy term infant aged 3 - 13 weeks;
- •Gestational age at birth 37- 42 weeks;
- •Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
- •Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
- •Fully formula fed for at least 7 days before screening/randomisation;
- •Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
排除标准
- •History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing;
- •Gastrointestinal infection within 4 weeks prior to randomisation;
- •Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator;
- •Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS);
- •Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement;
- •Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation;
- •Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements;
- •Current participation in another clinical intervention study.
研究组 & 干预措施
Fermented IF + LBG + Gos Fos
Active Comparator
Fermented infant formula with Locust bean gum and Gos Fos
干预措施: Anti-regurgitation infant formula (Other)
Fermented IF +LBG
Placebo Comparator
Fermented infant formula with Locust bean gum
干预措施: Anti-regurgitation infant formula (Other)
结局指标
主要结局
GI tolerance
时间窗: 4 weeks
To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale
次要结局
未报告次要终点
研究者
研究点 (2)
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