The Efficacy and Safety of the Probiotic Bacterium Lactobacillus reuteri DSM 17938 for Infantile Colic: A Meta-Analysis of Randomized Controlled Trials

PLoS One. 2015 Oct 28;10(10):e0141445. doi: 10.1371/journal.pone.0141445. eCollection 2015.


Objective: To evaluate the efficacy and safety of Lactobacillus reuteri DSM 17938 for treating infantile colic.

Methods: A systematic literature retrieval was carried out to obtain randomized controlled trials of L. reuteri DSM 17938 for infantile colic. Trials were performed before May 2015 and retrieved from the PubMed, EMBASE, Cochrane library, CNKI, WanFang, VIP, and CBM databases. Data extraction and quality evaluation of the trials were performed independently by two investigators. A meta-analysis was performed using STATA version 12.0.

Results: Six randomized controlled trials of 423 infants with colic were included. Of these subjects, 213 were in the L. reuteri group, and 210 were in the placebo group. Lactobacillus reuteri increased colic treatment effectiveness at two weeks (RR = 2.84; 95% CI: 1.24-6.50; p = 0.014) and three weeks (relative risk [RR] = 2.33; 95% CI: 1.38-3.93; P = 0.002) but not at four weeks (RR = 1.41; 95% CI: 0.52-3.82; P = 0.498). Lactobacillus reuteri decreased crying time (min/d) at two weeks (weighted mean difference [WMD] = -42.89; 95% CI: -60.50 to -25.29; P = 0.000) and three weeks (WMD = -45.83; 95% CI: -59.45 to -32.21; P = 0.000). In addition, L. reuteri did not influence infants' weight, length or head circumference and was not associated with serious adverse events.

Conclusions: Lactobacillus reuteri possibly increased the effectiveness of treatment for infantile colic and decreased crying time at two to three weeks without causing adverse events. However, these protective roles are usurped by gradual physiological improvements. The study is limited by the heterogeneity of the trials and should be considered with caution. Higher quality, multicenter randomized controlled trials with larger samples are needed.

Publication types

  • Meta-Analysis

MeSH terms

  • Colic / therapy*
  • Humans
  • Infant
  • Infant, Newborn
  • Lactobacillus reuteri*
  • Odds Ratio
  • Probiotics / administration & dosage*
  • Probiotics / adverse effects
  • Randomized Controlled Trials as Topic
  • Treatment Outcome

Grant support

The authors have no support or funding to report.