Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic: a Double Blind, Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration.
研究概览
简要总结
Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The variability in the prevalence of IC reported by the several studies depends on different criteria used to define IC.The etiology of IC remains still unclear. Recently, the composition of intestinal microbiome has been addressed as an independent risk factor for IC. There are no uniform criteria for a specific therapeutic approach of IC. Based on these conclusions the objectives of our study are: to determine whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration and in prolonging the duration of sleeping period
详细描述
BACKGROUND Definition Infantile Colic (IC) is one of the Functional gastrointestinal disorders (FGIDs) of infants/toddlers, which are defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. In 2006, the Rome III committee established a new criteria defining it as "episodes of irritability, fussing, or crying that begin and end for no apparent reason and last at least three hours a day, at least three days a week, for at least one week".
Epidemiology IC is responsible of 25% of pediatric consultation in the first 3-4 months of life affecting from 5% to 30% of infants between 2 weeks and 3 months of life. The variability in the prevalence of IC reported by the several studies depends on different criteria used to define IC.
In a systematic review of 15 community-based surveys on IC prevalence, carried out in 2001, the occurrence rates in the first 3 months of life were from 3% to 28% in prospective studies and from 8% and 40% in retrospective studies. In a prospective study found that 20.5% of 2879 Italian infants, aged 2 weeks-6 months, had IC.
Recently a French study reported a prevalence of IC in infants aged 0-4 months, of 19%. In two english studies, IC was reported in 18.3% and 26 % respectively, of infants aged 0-12 months. Other European studies were conducted with a different reported prevalence.
Outside Europe, a prevalence of 9.2% and of 20% respectively were reported by two studies carried out in US. More recently in an Israeli study of 94 mothers of 2-4 moths of life infants, 56% of those whose babies were breastfed and 73% of those using formula reported "paroxysmal irritability".
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-term infants (≥37 weeks gestation at birth); Exclusively formula fed infants at time of enrolment; Infants suffering from IC according to Rome III criteria (Appendix 1); Age < 4 months of life; 5-minute Apgar score ≥7; Birth weight ≥2500 g.
排除标准
- •Consumption of formula containing probiotics, pHF or with reduced lactose content at time of enrolment; Major medical problem or acute illness, including gastroesophageal reflux, cow's milk protein allergy History of antibiotic treatment before or during the study; History of probiotic or L reuteri supplementation; History of any allergies to any of the ingredients in the probiotic L reuteri Concurrent participation in another clinical trial. Birth weight < 2500 g; Failed to thrive; Breastfed infants; NAN (to avoid the formula switch effect).
结局指标
主要结局
whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration.
时间窗: 7, 14, 21, 28 days, 2 and 3 months
Infant crying duration (minutes per day) at 7, 14, 21, 28 days, 2 and 3 months post-intervention.
次要结局
- whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration.(28 days)
- the effect of a partially hydrolyzed formula (pHF) on quality of life of the enrolled patients(3 months)
- Parental perception of sleep quality (VAS 0-10)(28 days)
- the effect of a partially hydrolyzed formula (pHF) on quality of life of parents(3 months)
- the effect of this infant formula enriched with Lactobacillus reuteri on fecal microbiome of colicky infants(2 months)
- Parental perception of colic severity (VAS 0-10)(28 days)
- whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in increasing infant sleep.(7, 14, 21, 28 days, 2 and 3 months)
- Changes in stool frequency and consistency(28 days)
研究者
Annamaria Staiano
Professor of Pediatrics
Federico II University