A prospective study evaluating the effect of Lactobacillus reuteri DSM 17938 on crying time in fifty infants diagnosed with infantile colic, whereof 46 completed the trial (25 received Lactobacillus reuteri, 10^8 CFU once daily, and 21 placebo).
Faeces was analysed for changes in the numbers of certain members of the intestinal microbiota. The infants were all born at term, they were 2-16 weeks at recruitment, and exclusively breastfed during the study. The parents recorded the daily crying time, stool characteristics and any adverse events in a diary.
Median daily crying times in minutes/day were 370 vs. 300 on day 0 and 35.0 vs 90.0 (P=0.022) on day 21, in the Lactobacillus reuteri and placebo groups, respectively. The number of responders, defined as 50% reduction in crying time from baseline, was significantly higher in the Lactobacillus reuteri group versus the placebo group on days 7: 20 vs. 8 (P=0.006); day 14: 24 vs. 13 (P=0.007), and day 21: 24 vs 15 (P= 0.036). There was a significant increase in faecal lactobacilli (P=0.002) and a reduction in faecal E. coli in the Lactobacillus reuteri group only (P=0.001) during the study period. There were no differences in weight gain, defecation frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed.
Conclusion: Administration of Lactobacillus reuteri DSM 17938 to infants diagnosed with infantile colic reduced crying time significantly compared with placebo, and was well tolerated. The effect was seen already after one week, and it may be related to induced changes in the faecal microbiota, particularly E. coli.