Breastfed infants administered the probiotic Lactobacillus reuteri for colic were found to demonstrate a reduction in duration of crying and fussing, according to a meta-analysis published in Pediatrics.1 However, these findings were not demonstrated in formula-fed infants.

An international team of investigators reviewed 4 double-blind randomized controlled trials involving 345 infants with colic who were randomly assigned to probiotic treatment (n=174) or placebo (n=171) to determine the efficacy of L reuteri DSM17938 for reducing the duration of crying and/or fussing and if feeding type could influence treatment outcomes.

Probiotic and placebo were orally administered and consistent for probiotic product manufacturer and dosage across all 4 trials, all of which included breastfed infants (n=246) and 1 that included formula-fed infants (n=99).

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Within the 21-day trial, average crying/fussing duration was less in the probiotic cohort than the placebo cohort at all time points (day-21 adjusted average difference in change from baseline, -25.4 min), with the probiotic cohort demonstrating nearly twice the likeliness of treatment success than the placebo group (day-21 adjusted incidence ratio, 1.71).

Significant intervention effects were seen in breastfed infants (number needed to treat for day-21 success, 2.6); no significant results were noted for probiotic use in formula-fed infants.

The authors mentioned that “insufficient data to make conclusions for formula-fed infants” was a limitation of the study. They concluded that “L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic” and “[i]ts role in formula-fed infants with colic needs further research.”

Published in Annals of Emergency Medicine, commentators of a separate review2 of the study noted that approximately 20% of infants younger than 3 months are affected by colic and that previous studies suggest a variation in gut microbiome between infants with and without colic.

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“Overall, this meta-analysis demonstrates a potentially useful treatment for infant colic, most notably in the breastfed infant,” the authors wrote. “Further research is needed to gather information on the effects of the probiotic on formula-fed and breastfed infants because their gut microbiomes are known to have different compositions.”


1.      Sung V, D’Amico F, Cabana MD, et al. Lactobacillus reuteri to treat infant colic: a meta-analysis. Pediatrics. 2018;141(1):e20171811.

2.       FitzGibbon K, Ju NR. Can the probiotic Lactobacillus reuteri be used to treat infant colic? [published online October 26, 2018]. Ann Emerg Med. doi: 10.1016/j.annemergmed.2018.09.016