Original ArticleProbiotics for Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating Lactobacillus reuteri DSM 17938
Section snippets
Methods
This randomized, double-blind, placebo-controlled trial was carried out between February 2012 and April 2014 at The Hospital for Sick Children and in pediatric care practices in Toronto, Ontario, Canada. Before study initiation, approval was obtained from The Hospital for Sick Children's Research Ethics Board and Health Canada. Eligible infants were included in the study after written informed consent was obtained from a parent/guardian.
Study participants met the following inclusion criteria:
Results
A total of 186 infants were screened for eligibility based on the inclusion criteria. Parents of 123 eligible infants declined participation, and 8 infants did not meet the inclusion criteria. Overall, 55 eligible infants were randomized, 27 to receive placebo and 28 to receive L reuteri (Figure; available at www.jpeds.com). Three participants who were randomized to the L reuteri group were withdrawn from the study and thus were not included in the analysis for the following reasons (each
Discussion
Administration of L reuteri DSM 17938 to exclusively breastfed infants diagnosed with infantile colic proved superior to placebo in reducing daily crying and fussing times. The difference was statistically significant as early as 7 days after initiation of the probiotic therapy. Analysis of the number of responders to treatment revealed a similar trend by day 21 of treatment.
A few minor differences notwithstanding, our results are consistent with other previously reported studies from Italy and
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Supported by the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation. The probiotic and placebo were supplied by Ferring Canada, Inc. The authors declare no conflicts of interest.
Registered with ClinicalTrials.gov: NCT01541046.