Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation: A Randomized Clinical Trial | Emergency Medicine | JAMA Pediatrics | JAMA Network
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    1 Comment for this article
    Was infant feeding a confounder?
    Maureen Minchin | retired
    Can you please supply all relevant details of infant feeding data collected? How many -if any- children were exclusively breastfed from birth to study end?What duration of exclusive breastfeeding (If any) in others? How many were solely formula fed from birth to study end? Was a comparison of solely breastfed and solely formula-fed for the three months study period attempted or possible? What type of infant formula was used? how many parents changed formulas during the study, and was this significant? What detailed analysis of infant feeding as a potential confounder was undertaken, (or could be now undertaken from data collected) given the significant effects of feeds on infant microbiome, and the 700+spp in breastmilk? Were any comparative faecal flora studies done?
    Original Investigation
    Journal Club
    March 2014

    Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation: A Randomized Clinical Trial

    Journal Club PowerPoint Slide Download
    Author Affiliations
    • 1Department of Pediatrics, Aldo Moro University of Bari, Bari, Italy
    • 2Laboratory of Experimental Physiopathology, National Institute for Digestive Diseases, IRCCS “Saverio de Bellis,” Castellana Grotte, Italy
    • 3Division of Neonatology, Department of Pediatrics, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
    • 4Division of Neonatology, Department of Pediatrics, Ospedale S.S. Annunziata, Taranto, Italy
    • 5Division of Neonatology, Department of Pediatrics, S. Orsola-Malpighi University Hospital, Bologna, Italy
    • 6Division of Neonatology, Department of Pediatrics, University of Ferrara, Ferrara, Italy
    • 7Division of Neonatology, Department of Pediatrics, San Giovanni di Dio Hospital, Crotone, Italy
    • 8Department of Pediatrics, Ospedale Fracastoro, San Bonifacio, Italy
    • 9Division of Neonatology, Department of Pediatrics, Ospedale Sesto San Giovanni, Sesto San Giovanni, Italy
    • 10Division of Neonatology, Di Venere Hospital, Bari, Italy
    • 11Department of Biomedical Sciences and Human Oncology, Section of Hygiene, Aldo Moro University of Bari, Bari, Italy
    JAMA Pediatr. 2014;168(3):228-233. doi:10.1001/jamapediatrics.2013.4367

    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  To investigate whether oral supplementation with Lactobacillus reuteri DSM 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  A prospective, multicenter, double-masked, placebo-controlled randomized clinical 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  Parents were asked to record in a structured diary the number of episodes of 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  In total, 589 infants were randomly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days.

    Interventions  Prophylactic use of probiotic.

    Main Outcomes and Measures  Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation.

    Results  At 3 months of age, the mean duration of crying time (38 vs 71 minutes; 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.

    Conclusions and Relevance  Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

    Trial Registration Identifier: NCT01235884