March 17, 2014
Daily doses of live bacterial supplementation may reduce the occurrence and duration of diarrhea and respiratory tract infection (RTI) in preschool children, as well as lower the costs of treatment, according to a study published online March 17 inPediatrics.
Pedro Gutierrez-Castrellon, MD, DSc, from the National Perinatology Institute, Mexico City, Mexico, and colleagues conducted a randomized, double-blind, placebo-controlled trial at 4 day care centers near the institute between April 2011 and June 2012.
A computer-generated randomization placed 336 healthy children aged 6 to 36 months who were born at term (≥36 weeks' gestation) and who had similar socioeconomic characteristics in 2 equal-number groups. Half the children (168) received Lactobacillus reuteri DSM 17938 (1 × 108 colony-forming unit) and half (168) received placebo once a day for 12 weeks. All of the children completed the study with no breached protocols, the researchers report.
Parents gave the dropper doses on first feedings in the morning, and researchers assessed compliance on the basis of empty bottles returned and parent-kept diaries. Researchers instructed parents on how to monitor daily the stool consistency of their children and to report any respiratory symptoms. Confirmed RTI cases led to hospitalized or outpatient care.
L reuteri supplementation helped reduce the number of days with diarrhea per child from 0.96 (0.2) to 0.32 (0.1; P = .03) during the trial and from 1.1 to 0.5 (P = .01) during a 12-week follow-up period.
In addition, the researchers report that 99 episodes of diarrhea occurred among the L reuteri group compared with 152 episodes among the placebo group (P = .01). Diarrhea lasted an average of 1.6 ± 0.9 days in the L reuteri group and 2.7 ± 1.1 days in the placebo group (P = .02).
L reuteri supplementation helped reduce the number of days with RTI per child from 4.6 (1.8) to 1.5 (0.6; P = .01) during the trial and from 4.4 (1.1) to 2.1 (0.8; P = .01) during follow-up.
L reuteri supplementation also helped significantly reduce the number of days of school absences (P = .03), the number of healthcare visits (P = .04), and the number of days of antibiotic use (P = .04) during the trial and in follow-up. In a cost–benefit analysis, the first such analysis they are aware of, the researchers found that L reuteri supplementation also helped reduce healthcare costs.
"The prophylactic use of L reuteri was associated with a reduction of $36 US dollars (USD) for each case of diarrhea and $37 USD for each case of RTI," the researchers write. They calculated the incremental cost effectiveness ratio at −35.7 for diarrhea and −37.4 for RTI.
"This study adds independent support to previously published evidence that can now be used in systematic reviews to establish evidence-based recommendations for the use of L reuteri DSM 17938 in the prevention of infectious diseases in day care Centers," the researchers conclude.
This research was supported by GioGaia AB, Stockholm, Sweden, who supplied the L reuteri and placebo products used in the trial. The authors have disclosed no relevant financial relationships.
Pediatrics. Published online March 17, 2014. Abstract