Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Crying time
研究概览
简要总结
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.
详细描述
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.
The objective of the present study is to compare the effect of B. brevis and B. brevis\L mixture. fermentum with respect to simethicone.
It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).
入排标准
- 年龄范围
- 3 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants from 3 to 12 weeks of age
- •Born at least at week 34
- •Birth weight equal to or greater than 2000 grams
- •Fulfill the criteria of Rome III
- •Informed consent signed by parents or guardians
排除标准
- •Failure to thrive
- •Antibiotic treatment less than 2 weeks before the study or during the study
- •Take probiotics as a treatment, different from the one that could contain the powdered infant formula
- •Abandon breastfeeding and switch to infant formula
- •Failure to comply with the study protocol
研究组 & 干预措施
B. breve
Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.
干预措施: B. breve (Dietary Supplement)
B. breve plus L. fermentum
Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.
干预措施: B. breve plus L. fermentum (Dietary Supplement)
Simethicone 20 mg
Control group that will receive simethicone 4 times (10 drops) a day.
干预措施: Simethicone 20 MG (Drug)
结局指标
主要结局
Crying time
时间窗: 4 weeks
Crying time in minutes per day
次要结局
- Responders to treatment on weeks 1, 2, 3 and 4(4 weeks)
- Gut microbiota(4 weeks)
- Stool carbohydrates(4 weeks)
研究者
Mónica Olivares Martín; PhD
Head of the R & D Department
Biosearch S.A.