Image: CC/Wiki/Blaylock. Lactobacillus
1. Daily use of prophylactic probiotics was associated with decreased colic, regurgitation, and constipation during the first three months of life.
2. Use of prophylactic probiotics was associated with reduced overall cost for both the family and community.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Findings from this multicenter double-blinded randomized, controlled trial (RCT) demonstrated that daily prophylactic supplementation with an oral probiotic for the first three months of life resulted in a significant decrease in colic, regurgitation, and constipation. The intervention also demonstrated cost savings for both individual families and the general community. This is one of the first studies to assess the use of probiotics as a preventive measure for functional gastrointestinal disease in infants.
Strengths of this study include large sample size, parsimonious design and low loss to follow-up rate (17%). Results from the cost-benefit analysis, while significant in this Italian cohort, may not be applicable to the U.S. or other economies. Future studies might attempt to reproduce results in a U.S. cohort and employ longer follow-up times.
Relevant Reading: Probiotics and Prebiotics in Pediatrics
In-Depth [randomized controlled trial]: Newborns from nine hospitals in Italy were randomized to receive probiotic (L reuteri DSM 17938; n=276) or placebo (n=278) daily for 90 days. Primary outcomes of daily crying time, regurgitation episodes, and number of stools during the first three months of life were assessed by parental diaries. Cost-benefit analysis was performed and compared costs of the probiotic, number of healthcare visits or hospitalizations, feeding changes, pharmacologic interventions, and loss of parental workdays in either treatment arm.
Parents of infants who took a daily prophylactic probiotic reported less crying (37.7 vs. 70.9 min/day, p<.01) less regurgitations (2.9 vs. 4.6/day, p<.01), and more bowel movements per day (4.2 vs. 3.6/day, p<.01). Parents of these infants also reported significantly fewer healthcare visits, loss of parental workdays, and use additional medications, resulting in a savings of US $118.71 for the family and US $140.30 for the community. No adverse events were reported.
By Maren Shapiro and Leah Hawkins, MD, MPH
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