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. Author manuscript; available in PMC: 2018 Feb 1.
Published in final edited form as: Neurogastroenterol Motil. 2016 Sep 20;29(2):10.1111/nmo.12943. doi: 10.1111/nmo.12943

Table 1.

Trials with L. reuteri Strains in Infantile Colic

Author, Year
(ref. #)		 Type of Study/Study
Population/Intervention		 Outcomes Results
Savino et al.
2007 (69)
  • -

    Prospective, open-label, randomized controlled trial.

  • -

    83 breastfed infants.

  • -

    L. reuteri ATCC 55730 (108 CFU), once a day for 28 days vs. simethicone (60 mg/day), twice a day for 28 days.
  • -

    Reduction in daily average crying time.
  • -

    Significant reduction in daily median crying times in probiotic group vs. simethicone group at day 28 (p<0.001).
Savino et al.
2010 (96)
  • -

    Randomized, double-blind, placebo-controlled trial.

  • -

    46 exclusively breastfed infants

  • -

    L. reuteri DSM 17938 vs. placebo, once a day for 21 days.
  • -

    Primary outcome: reduction of average crying time on day 21.

  • -

    Secondary outcomes: number of “responders” (those who experienced a decrease in the daily average crying time of 50% from baseline) in each group on days 7, 14, and 21; effects on the intestinal microbiota.
  • -

    Significant reduction in daily median crying time in the probiotic group vs. placebo group (p=0.22), at day 21.

  • -

    Significantly higher number of responders in the probiotic group compared with placebo group, at times 7, 14, and 21 (p=0.006, p=0.007, and p=0.36, respectively).

  • -

    Significant increase in fecal Lactobacilli (p=0.002), and reduction in fecal Escherichia coli in the probiotic group (p=0.001). No differences for Bifidobacteria and C. butyricum.
Szajewska et al.
2013 (71)
  • -

    Randomized, double-blind, placebo-controlled trial.

  • -

    80 exclusively or predominantly (>50%) breastfed infants

  • -

    L. reuteri DSM 17938 (108 CFU) vs. placebo, once a day for 21 days.
  • -

    Primary outcomes: “treatment success” (reduction in the daily average crying time ≥50%) at days 7, 14, 21 and 28; duration of crying (minutes/day).

  • -

    Secondary outcomes: reduction in daily average crying time; persistence of IC after the intervention; parental perception of colic severity; parental/family quality of life.
  • -

    Treatment success significantly higher in the probiotic group vs. the placebo group, at all time points (p<0.05).

  • -

    Significant reduction of median daily crying time in the probiotic group at days 14, 21 and 28 (p<0.0001).

  • -

    Significant reduction in parental perception of colic severity, and improved parental/family quality of life in the probiotic group compared with the placebo group (p<0.0001).
Sung et al.
2014 (70)
  • -

    Randomized, double-blind, placebo-controlled trial.

  • -

    167 breastfed or formula-fed infants

  • -

    L. reuteri DSM 17938 (108 CFU) vs. placebo (maltodextrin), once a day for 28 days.
  • -

    Primary outcome: daily duration of cry or fuss at 1 month

  • -

    Secondary outcomes: duration of cry or fuss episodes; number of cry or fuss episodes; sleep duration of infants; maternal mental health; family functioning; parents quality of life; infants functioning; infant fecal microbiota; calprotectin levels.
  • -

    At 1 month, the probiotics group cried or fussed 49 minutes/day more than the placebo group (p=0.02). Difference mainly due to more fussing in the probiotic group (p=0.002).

  • -

    No significant difference in all secondary outcomes.
Chau et al.
2015 (63)
  • -

    Randomized, double-blind, placebo-controlled trial.

  • -

    52 exclusively breastfed infants.

  • -

    L. reuteri DSM 17938 (108 CFU) vs. placebo, once a day for 21 days.
  • -

    Primary outcome: reduction in the duration of average crying and fussing times, from baseline to day 21, to <3 hours/day.

  • -

    Secondary outcomes: number of “responders” to treatment (those who experienced a decrease in the daily average crying and/or fussing time ≥50% from baseline) on days 7, 14 and 21.
  • -

    Total average crying and fussing times shorter in the L. reuteri group vs. the placebo group (p=0.028).

  • -

    Significantly greater reduction in daily crying and fussing times in the probiotic group vs. placebo group (p=0.045), at the end of the treatment.
Mi et al.
2015 (67)
  • -

    Randomized, single-blind, placebo-controlled trial.

  • -

    39 exclusively or predominantly breastfed infants.

  • -

    L. reuteri DSM 17938 (108 CFU) vs. placebo, once a day for 28 days.
  • -

    Primary outcome: “treatment success” (reduction in the daily average crying time ≥50%).

  • -

    Secondary outcomes: mean reduction of daily average crying time, parental satisfaction, and reduction in maternal depression.
  • -

    Treatment success in 100% of the probiotic group vs. 15.7% of placebo group (p<0.01), at the end of the treatment period.

  • -

    Significant reduction in daily crying time in the probiotic group (p<0.01).

  • -

    Significant improvement of parental satisfaction and maternal depression (p<0.01)

CFU: colony forming unit