Elsevier

The Journal of Pediatrics

Volume 166, Issue 1, January 2015, Pages 74-78.e1
The Journal of Pediatrics

Original Article
Probiotics for Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating Lactobacillus reuteri DSM 17938

https://doi.org/10.1016/j.jpeds.2014.09.020Get rights and content

Objective

To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants, compared with placebo.

Study design

A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (108 colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.

Results

Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P = .045). On day 21, a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P = .035; relative risk, 3.3; 95% CI, 1.55-7.03).

Conclusion

Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic.

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.

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