NCT06488274招募中不适用
Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 4
- 主要终点
- Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score
研究概览
简要总结
This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.
详细描述
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
- •1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:
- •Infants born at 35 weeks or more of gestational age
- •Infants up to 4 months of age
排除标准
- •Exclusively or partially breastfed infants (i.e. > 2 breast feeds per day) with maternal willingness to continue breastfeeding
- •Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
- •Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
- •The willingness to take additional pre-, probiotics or thickening agents during the study
- •Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
- •Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient
- •(non exhaustive list)
结局指标
主要结局
Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score
时间窗: Day 30
The main outcome will be the evolution of the sum score of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale (Pados et al., 2021). The GIGER score varies from 0 to 180 being the worst.
次要结局
- Regurgitation severity(Day 14, Day 30, Day 60, Day 90, Day 120)
- Investigator's evaluation of the evolution of FGIDs(Day 14, Day 30, Day 60, Day 90, Day 120)
- Height(Day 30, Day 60, Day 90, Day 120)
- Stool frequency and consistency in non constipated infant(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Stool frequency and consistency in constipated infant(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Colic(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Abdominal distension severity(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- GIGER score(Day 7, Day 14, Day 60, Day 90, Day 120)
- Number of bottles at night(D7, D14, D30, D60, D90, D120)
- Parents' satisfaction(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Regurgitation frequency(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Weight(Day 30, Day 60, Day 90, Day 120)
- Gas/flatulence severity(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- BMI(Day 30, Day 60, Day 90, Day 120)
- Evolution of FGIDs (regurgitations, colic and constipation)(Day 14, Day 30, Day 60, Day 90, Day 120)
- Defecation pain frequency in constipated infant(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Infant's quality of life(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Adverse events(Through study completion (up to 30 days or 120 days if participation to the optional intervention period))
- Sleep(Day 7, Day 14, Day 30, Day 60, Day 90, Day 120)
- Head circumference(Day 30, Day 60, Day 90, Day 120)
研究者
研究点 (4)
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