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J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.

Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial.

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  • 1Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.

Abstract

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 (10(8) 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01046617.

Copyright © 2013 Mosby, Inc. All rights reserved.

PMID:
22981952
[PubMed - indexed for MEDLINE]
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