An Observational Prospective Study to Evaluate the Efficacy of 2 Weeks of Oral Supplementation With a Probiotic Formula in Infants With Functional Gastrointestinal Disorders (FGDI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in total FGDI severity
研究概览
简要总结
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
详细描述
Functional gastrointestinal disorders (FGDIs) affect one out of two infants during the fist six months of life and do not have an organic cause. Infant colic, so-called excessive crying syndrome, and functional constipation are among the most common paediatric FGDIs.
FGDIs pathophysiology is multifactorial and may include phycological factors and alterations of the gut physiology including gut microbiota dysbiosis.
Probiotics are proposed as a potential treatment for FGDIs. However, evidence is limited.
A probiotic formula composed of strains Bifidobacerium longum CECT 7894 and Pediococcus pentosaceus CECT 8330 is tested in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastrointestinal symptoms related to FGID including functional constipation and/or infant colic diagnosed according to Rome IV criteria for clinical purposes.
- •≥ 37 weeks of gestation at birth.
- •≥ 2500 g of birth weight.
排除标准
- •Infants with failure to thrive (weight gain <100 grams/week on average from birth).
- •Major medical problems (e. g. immunodeficiencies, developmental problems or genetic abnormalities)
- •Gastrointestinal diseases
- •Administered with antibiotics for 4 weeks or probiotics for 2 weeks before or during study
结局指标
主要结局
Change in total FGDI severity
时间窗: Day 1 and day 14
FGDI severity measured as summatory of excessive crying score (5-point Likert scale (0: no symptoms, to 4: extremely severe symptoms) + constipation score (5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)
次要结局
- Change in excessive crying severity(Day 1 and day 14)
- Change in constipation severity(Day 1 and day 14)
- Change in parental anxiety(Day 1 and day 14)
- Tolerability and safety(Daily from day 1 to day 14)
- Parental satisfaction with the product(Day 14)