Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 12
- 主要终点
- Frequency of regurgitation
研究概览
简要总结
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
详细描述
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).
The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
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
- 2 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
- •exclusive or predominant formula feeding
- •whose parents signed informed consent
排除标准
- •preterm infants or birthweight <2500g
- •Post enteritis lactose intolerance
- •Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
- •Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
- •Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject
研究组 & 干预措施
Test
new thickened infant formula containing fibres
干预措施: Experimental Infant formula (Other)
Control
infant formula thickened with locust bean
干预措施: Infant formula thickened with locust bean gum (Other)
结局指标
主要结局
Frequency of regurgitation
时间窗: Day 14
Decrease of the daily number of regurgitation between baseline and day 14
次要结局
- Frequency of regurgitations(Day 30, Day 90)
- Severity of regurgitation episodes(Day 14, Day 30, Day 90)
- Stools' frequency(Day 14, Day 30, Day 90)
- Stools' consistency(Day 14, Day 30, Day 90)
- Frequency of diarrhea(Day 14, Day 30, Day 90)
- Anthropometric parameters - Weight-for-height z-score(Day 14, Day 30, Day 90)
- Severity of diarrhea(Day 14, Day 30, Day 90)
- Frequency of constipation(Day 14, Day 30, Day 90)
- Severity of constipation(Day 14, Day 30, Day 90)
- Crying time(Day 14, Day 30, Day 90)
- Feeding refusal(Day 14, Day 30, Day 90)
- Abnormal posturing(Day 14, Day 30, Day 90)
- Sleep quality(Day 14, Day 30, Day 90)
- Anthropometric parameters - Weight(Day 14, Day 30, Day 90)
- Anthropometric parameters - Length(Day 14, Day 30, Day 90)
- Anthropometric parameters - Head circumference(Day 14, Day 30, Day 90)
- Anthropometric parameters - BMI(Day 14, Day 30, Day 90)
- Use of drug treatments(Day 14, Day 30, Day 90)
- Parents' satisfaction(Day 14, Day 30, Day 90)
- Investigator's satisfaction(Day 14, Day 30, Day 90)