NCT04042454已完成不适用
A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
Nutricia Research16 个研究点 分布在 3 个国家目标入组 103 人开始时间: 2019年12月10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
- 103
- 试验地点
- 16
- 主要终点
- Average stool consistency
研究概览
简要总结
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton infants with regurgitation who are otherwise healthy
- •Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
- •Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
- •Aged > 3 weeks (21 days) and < 9 weeks (63 days) at screening
- •Exclusively formula fed for ≥ 7 days before screening
- •Written informed consent from the parent(s) and/or legally acceptable representative(s)
排除标准
- •Low birth weight for gestational age and gender
- •Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
- •Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation
- •Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
- •Infants who already started complementary feeding
- •Infants with a gastrointestinal infection within 4 weeks prior to screening
- •Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator
- •Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet
- •Infants known or suspected to have allergy to cow's milk protein
- •Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
- •Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
- •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
研究组 & 干预措施
Test Product
Experimental
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
干预措施: milk based anti-regurgitation infant formula (Other)
Control Product
Active Comparator
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
干预措施: Milk based infant formula (Other)
结局指标
主要结局
Average stool consistency
时间窗: 8 weeks
The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale \[BITSS\]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference.
次要结局
- IGSQ sum and individual item scores(2, 4, 8, 17 weeks)
- To assess the average stool consistency(8 weeks)
- The average stool frequency(8 weeks)
- Incidence of diarrhoea:(8 weeks, 17 weeks)
- Gut microbiota composition and function(17 weeks)
- Regurgitation(2,4,8,17 weeks)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
不适用
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)Nutritional SafetyNCT00486148Heinz Italia SpA360
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
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
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
The Trial of a New Infant Formula in Healthy Term Chinese InfantsHealthy InfantsNCT06053112Junlebao Dairy Group Co., Ltd.326