The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- BioGaia AB
- 试验地点
- 2
- 主要终点
- The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.
详细描述
NOTE: The study never started.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusively breastfed Infants
- •Infant aged of 29 days to 3 months
- •With a diagnosis of infantile colic as defined by the Rome III criteria
- •Birth at term and eutrophic (weight, height, head circumference)
- •Apgar score> 7 at 5 minutes
- •Consent to the study signed by the two parents.
- •Availability during the study period
排除标准
- •Associated severe chronic disease
- •Acute infectious disease
- •Personal or family first degree history of allergy to milk proteins
- •Several infants of the same family from a multiple pregnancy
- •Infants who received antibiotics one week prior to randomization
- •Infants who received probiotics one week prior to randomization
- •Mother who received antibiotics 1 week before randomization
- •Regular consumption of probiotics by the mother 1 week before randomization
- •Infants-included in another clinical study
- •Lack of insurance coverage by the french social security
- •Non exclusively breastfed infants
结局指标
主要结局
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.
时间窗: day 7
次要结局
- The responders rates at D14 and D21 in the probiotic group compared to the placebo group.(Day 14 and day 21)