Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation

IMPORTANCE Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences.

OBJECTIVE ToinvestigatewhetheroralsupplementationwithLactobacillusreuteriDSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions.

DESIGN Aprospective,multicenter,double-masked,placebo-controlledrandomizedclinical trial was performed on term newborns (age <1 week) born at 9 different neonatal units in Italy between September 1, 2010, and October 30, 2012.

SETTING Parentswereaskedtorecordinastructureddiarythenumberofepisodesof regurgitation, duration of inconsolable crying (minutes per day), number of evacuations per day, number of visits to pediatricians, feeding changes, hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days.

PARTICIPANTS Intotal,589infantswererandomlyallocatedtoreceiveLreuteriDSM17938or placebo daily for 90 days.

INTERVENTIONS Prophylacticuseofprobiotic.

MAINOUTCOMESANDMEASURES Reductionofdailycryingtime,regurgitation,and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation.

RESULTS At3monthsofage,themeandurationofcryingtime(38vs71minutes;P<.01),the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L reuteri DSM 17938 and placebo groups, respectively, were significantly different. The use of L reuteri DSM 17938 resulted in an estimated mean savings per patient of €88 (US $118.71) for the family and an additional €104 (US $140.30) for the community.

CONCLUSIONSANDRELEVANCE ProphylacticuseofLreuteriDSM17938duringthefirst3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

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