Clinical Trial: Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic: a Double Blind, Randomized-controlled Trial

Brief Summary: 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

Detailed Summary:

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".

Infant crying duration (minutes per day) at 7, 14, 21, 28 days, 2 and 3 months post-intervention.