Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- Change in mean cry/fuss time (min/day) from day 0 through day 28
研究概览
简要总结
The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC. The active group of infants will receive lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups
详细描述
There is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant colic, the condition that affects around 1 of 4-5 infants. The interest for dietary supplementation has been evoked by a line of earlier studies, indicating that infants with colic had an increased number of gas-forming E.coli in the intestines and potential interference between lactobacilli and E.coli. Systematic review of evidence, based on the 6 randomized controlled dietary studies, conducted in Italy, Poland, Australia, Canada, and Finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day after the 3 weeks dietary course with lactobacilli . In the mentioned studies most commonly used lactobacilli were L. reuteri, however, the effect of combination of L. reuteri with other lactobacilli remains unknown.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed by both parents.
- •Gender: males and females;
- •Age: 4 -12 weeks;
- •Infant colic, defined as cry/fussing lasting > 3 h, occurring > 3 d for 7 days;
- •Gestational age 37-42 weeks;
- •Birth weight 2,500-4,200 g;
- •Stated availability throughout the study period;
- •Sated availability of mobile phone or phone with answering machine.
排除标准
- •Any formula feeding in any amount;
- •Failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry);
- •Current maternal smoking;
- •Known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune);
- •Present intake of antibiotics by infant or mother;
- •Present intake of prebiotics or probiotics by infant or mother;
- •Difficulty of parents to comprehend study requirements as judged by the physician;
- •Suspected parental alcohol or drug addiction as judged by the physician.
研究组 & 干预措施
Drops with lactobacilli and vitamin D3
Exclusive breast feeding plus L. rhamnosus 19070-2 and L. reuteri DSM 12246 in a dose of 125 x 106 CFU (both strains) with 1,667 mg fructooligosaccharides and 2,5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days.
干预措施: Drops with lactobacilli and vitamin D3 (Dietary Supplement)
Drops with vitamin D3
Exclusive breast feeding plus 2.5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days.
干预措施: Drops with vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in mean cry/fuss time (min/day) from day 0 through day 28
时间窗: 28 days
Change in mean cry/fuss time
次要结局
- Recovery success (percent) at 7, 14, 21, 28 days, defined as reduction in duration of cry time less than 3 hours per day (unmet Wessel criteria);(7, 14, 21, 28 days)
- Cry and fuss time (min/day) on days 0, 7, 14, 21, 28(7, 14, 21, 28 days)
- Change in mean cry time (min/day) from day 0 through day 28(28 days)
- Change in mean fuss time (min/day) from day 0 through day 28(28 days)
- Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline(7, 14, 21, 28 days)