Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 478
- 主要终点
- Event number of colic
研究概览
简要总结
Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs.
There is now enough evidence for the treatment of colic using probiotics, especially Lactobacillus reuteri.
The investigators study aims to demonstrate the utility for the prevention of colic with L. reuteri and thereby avoid the problems caused by this pathology.
Objective: Compare the number of events of colic among infants with oral probiotic Lactobacillus reuteri during the first month of life versus infants with placebo
Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. The investigators trial will be performed at Naval Hospital in Mexico City.
详细描述
Methods:
This study is planned for October 2015 to October 2016 aiming newborns born population in Naval Hospital
Inclusion:
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
- Availability during the study period.
- Thorough understanding of the protocol by parents
- Informed Consent is signed by both parents.
Exclusion:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation.
- •Appropriate weight for gestational age
- •≥than 8 Apgar at 5 minutes
- •Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- •No congenital or physical abnormalities on physical examination at birth.
- •Availability during the study period.
- •Thorough understanding of the protocol by parents
- •Informed Consent is signed by both parents.
排除标准
- •Administration of antibiotics to the mother for a week before the birth of the newborn.
- •Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- •Medication Management newborn different routine prescribed at birth.
结局指标
主要结局
Event number of colic
时间窗: 3 months
次要结局
未报告次要终点
研究者
Dr. Jorge Ivan Valencia Moncada
Prevention of colic with the probiotic Lactobacillus reuteri DSM 17938 in Mexican infants: randomized, double-blind study
Hospital General Naval de Alta Especialidad - Escuela Medico Naval