A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Crying time
研究概览
简要总结
The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.
详细描述
Infantile colic ıs one of the most common problems within the first 3 months of life, affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome characterized by paroxysmal, excessive, inconsolable crying without identifiable cause. Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data demonstrated safety after long-term dietary supplementation for newborn infants. The positive effects of this probiotic on intestinal disorders such as constipation and diarrhea and in protection from infection,as well as its capacity to modulate immune responses.
The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants three weeks to three months
- •infants with colic three hours of crying on three days in the week
- •infants feeding with breast milk
- •infants weighing 2500 to 4000 gram
排除标准
- •chronic illness
- •gastrointestinal disorders
- •infants received either antibiotics or probiotics in the previous week
结局指标
主要结局
Crying time
时间窗: 3 weeks
Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks
次要结局
- postpartum depression(3 weeks)
研究者
Dilek Dilli
Assoc Prof
Dr. Sami Ulus Children's Hospital
