Elsevier

The Journal of Pediatrics

Volume 162, Issue 2, February 2013, Pages 257-262
The Journal of Pediatrics

Original Article
Lactobacillus reuteri DSM 17938 for the Management of Infantile Colic in Breastfed Infants: A Randomized, Double-Blind, Placebo-Controlled Trial

https://doi.org/10.1016/j.jpeds.2012.08.004Get rights and content

Objective

To determine whether administration of Lactobacillus reuteri (L reuteri) DSM 17938 is beneficial in breastfed infants with infantile colic.

Study design

Eighty infants aged <5 months with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment), who were exclusively or predominantly (>50%) breastfed were randomly assigned to receive L reuteri DSM 17938 (108 colony-forming units) (n = 40) or an identically appearing and tasting placebo (n = 40), both orally, in 5 drops, 1 time daily, for 21 days. The primary outcome measures were the treatment success, defined as the percentage of children achieving a reduction in the daily average crying time ≥50%, and the duration of crying (minutes per day) at 7, 14, 21, and 28 days after randomization.

Results

The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 (P = .026), at day 14 (relative risk (RR) 4.3, 95% CI 2.3-8.7), at day 21 (RR 2.7, 95% CI 1.85-4.1), and at day 28 (RR 2.5, 95% CI 1.8-3.75). In addition, throughout the study period, the median crying time was significantly reduced in the probiotic group compared with the control group.

Conclusion

Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo.

Section snippets

Methods

The standards from the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) were followed for this RCT. The trial was registered at ClinicalTrials.gov (NCT01046617). All infants were eligible for recruitment after written informed consent was obtained from their parents. The study was approved by the Ethics Committee of the Medical University of Warsaw.

The study was carried out between January 2010 and December 2011 in a family primary care practice in Warsaw, Poland. To be

Results

The Figure is a flow diagram showing the subjects' progression through the study. The intention-to-treat population included 80 infants—40 were assigned to the probiotic group and 40 were assigned to the placebo group. Baseline demographic and clinical characteristics did not differ between the 2 groups, except for a family history of allergy that was higher in the probiotic group compared with the placebo group (21/40 vs 7/40 infants) (Table I).

The treatment success rate was significantly

Discussion

Administration of L reuteri DSM 17938 at a dose 108 colony-forming units to exclusively or predominantly breastfed infants is superior to placebo for the management of infantile colic. The use of L reuteri was associated with the treatment success and reduced crying times at 1, 2, 3, and 4 weeks after randomization. No adverse events were recorded during the treatment.

In principle, our findings are consistent with the findings of a previous smaller trial by Savino et al,7 which used the same

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    Funded by the Medical University of Warsaw, which received a donation from the manufacturer of L reuteri DSM 17938, BioGaia AB, Lund, Sweden. The manufacturer had no role in the conception, design, or conduct of the study, or in the analysis or interpretation of the data. The authors declare no conflict of interest.

    Registered at ClinicalTrials.gov: NCT01046617.

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