Evaluation of the Efficacy of a New Specific Infant Formula With a Prebiotic and Probiotics in Case of Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Hard stool consistency or painful defecation
研究概览
简要总结
This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.
详细描述
The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.
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)
盲法说明
The allocation of the formula to each infant is drawn according to a randomization list developed using a software by the clinical research organization in charge of statistics and known only to him until the blind is lifted, i.e. after the statistical analysis. A 1:1 double-blind randomisation will be computer-generated by block (in each center).
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants having completed the selection period and still compliant with non-selection criteria
- •Infants being constipated according to modified Rome IV criteria based on information recorded in parents' diary during the week preceding visit V0 (inclusion visit)
排除标准
- 未提供
结局指标
主要结局
Hard stool consistency or painful defecation
时间窗: 30 days
Proportion of hard or painful stools per total number of spontaneous bowel movements by participant. A spontaneous bowel movement is defined as described in outcome 2. Stool consistency will be evaluated based on the Brussels Infant and Toddler Stool Scale (BITSS). BITSS is a reliable instrument to assess stools of non-toilet trained children. It consists of color photographs of nappies containing stools from infants and toddlers categorized as hard, formed, loose, or watery (Huysentruyt et al., 2019). The consistency and painful defecation of each stool will be assessed by parents at Day 30.
次要结局
- Painful defecation(30, 60, 90 and 120 days)
- Excessive stool retention(30, 60, 90 and 120 days)
- Treatment success(30, 60, 90 and 120 days)
- Weight(30, 60, 90 and 120 days)
- BMI(30, 60, 90 and 120 days)
- Rescue medication use(30, 60, 90 and 120 days)
- Stool consistency(30, 60, 90 and 120 days)
- Large diameter stools(30, 60, 90 and 120 days)
- Height(30, 60, 90 and 120 days)
- Sleep time satisfaction(30, 60, 90 and 120 days)
- Gut microbiota composition(0 and 60 days)
- Short-chain fatty acids (SCFAs)(0 and 60 days)
- Total and spontaneous defecation frequency(30, 60, 90 and 120 days)
- Head circumference(30, 60, 90 and 120 days)
- Nutritional status(0 and 60 days)
- Crying time(30, 60, 90 and 120 days)
- Parents' quality of life (QoL)(30, 60, 90 and 120 days)
- Adverse events(Through study completion, i.e. 67 days or 127 days if participation to the optional follow-up period)
- Regurgitations(30, 60, 90 and 120 days)
- Sleep quality(30, 60, 90 and 120 days)
- Parents' satisfaction(30, 60, 90 and 120 days)