Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Improvement of colics symptoms
研究概览
简要总结
Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians.
It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.
详细描述
Aim of the study is to evaluate the improvement of colics symptoms by the oral administration of VSL#3 and the difference in the daily average crying time (measured with parental diary) between end of treatment and baseline.
In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or Placebo according to randomization list. The study product will be supplied as a box containing the oil bottle and a powder stick. The product should be stored refrigerated. On the first day of supplementation, the mother will open the sachet, pour the contents into the bottle and shake vigorously. A dropper is provided to count the drops. The suspension must be shaken vigorously before every use. Compliance will be monitored by filling out a diary.
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
- 30 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged between 30 and 90 days
- •Breast fed exclusively during length of trial
- •Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
- •Debut of colic symptoms 6+/-1 days before randomization
- •Written informed consent from one or both parents
- •Stated availability and reliability throughout the study period.
排除标准
- •Major chronic disease
- •Gastrointestinal disease
- •Administration of antibiotics the week before randomization
- •Administration of probiotics two weeks before randomization
- •Infants with GI malformation, cystic fibrosis, other genetic diseases
- •Participation in other clinical trials.
研究组 & 干预措施
VSL#3 drops
31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
干预措施: VSL#3 drops (Dietary Supplement)
VSL#3 drops placebo
31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
干预措施: VSL#3 drops placebo (Dietary Supplement)
结局指标
主要结局
Improvement of colics symptoms
时间窗: 3 weeks
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
次要结局
- Difference in the daily average crying time between end of treatment and baseline.(3 weeks)
研究者
Prof. Maria Elisabetta Baldassarre
Professor of Pediatrics
Policlinico Hospital