Effects of Simethicone and Vivatlac Baby in Infantile Colic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
研究概览
简要总结
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
详细描述
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.
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
- None
入排标准
- 年龄范围
- 3 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed for infantile colic according to Wessel's criteria
排除标准
- •previous treatment with probiotic or synbiotic
- •previous treatment with antibiotics
研究组 & 干预措施
Simethicone Solution
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
干预措施: Simethicone Solution (Drug)
Vivatlac Baby
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.
干预措施: Vivatlac Baby (Dietary Supplement)
结局指标
主要结局
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
时间窗: Three weeks
Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
时间窗: Three weeks
Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
时间窗: Three weeks
Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
次要结局
未报告次要终点