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临床试验/NCT01855269
NCT01855269已完成不适用

A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic

Dr. Sami Ulus Children's Hospital2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2012年4月1日最近更新:
适应症

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

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

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

Assoc Prof

Dr. Sami Ulus Children's Hospital

研究点 (2)

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