From Medscape Medical News
August 16, 2010 — Supplementation with the probiotic Lactobacillus reuteri DSM 17 938, at a dose of 108 colony-forming units per day, improved the symptoms of infantile colic in breastfed infants and was well-tolerated and safe, according to a new study published online August 16 in Pediatrics.
"Colic affects 3% to 28% of infants, causing considerable stress and concern for parents, and the pathogenesis of the condition remains elusive, although evidence suggests multiple independent causes," write Francesco Savino, MD, PhD, from the University of Turin, Italy, and colleagues. "Recently, coliform bacteria, particularly Escherichia coli, were found to be more abundant in the feces of colicky infants, suggesting a role for coliform colonic fermentation and consequent excessive intraintestinal air production, aerohagia, and pain, typical in crying infants."
The aim of this study was to test the efficacy of L reuteri on infantile colic and to evaluate its relationship to the gut microbiota.
The study randomly assigned 50 colicky exclusively breastfed infants aged 2 to 16 weeks to receive either L reuteri or placebo daily for 21 days. Colic was defined according to modified Wessel's criteria as episodes of fussy crying that lasted 3 or more hours a day and episodes that lasted for 3 or more days in the week before enrollment in the study.
Both L reuteri and placebo formulations were given in 5 drops, once a day, 30 minutes before the infants' daily morning feed. The parents filled out a structured diary to record daily crying time in minutes, stool characteristics and frequency, and any adverse effects, such as constipation, vomiting, and skin reactions. Forty-six infants completed the study — 25 in the L reuteri group and 21 in the placebo group.
At the start of the study, daily crying times were similar in both groups. The median crying time in the L reuteri group was 370 minutes per day (interquartile range [IQR], 120 minutes) and 300 minutes per day (IQR, 150 minutes) in the placebo group (P = .127).
At the end of the study, the median daily crying times were 35.0 minutes per day (IQR, 85 minutes) in the L reuteri group vs 90.0 minutes per day (IQR, 148 minutes) in the placebo group (P = .022).
The authors also report that the number of responders, defined as having a 50% reduction in crying time from baseline, were significantly higher in the L reuteri group than in the placebo group on days 7 (20 vs 8; P = .006), 14 (24 vs 13; P = .007), and 21 (24 vs 15; P = .036).
The study also found a significant increase in fecal lactobacilli (P = .002) and a reduction in fecal E coli and ammonia in the L reuteri group only (P ≤ .001).
There were no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events associated with supplementation with L reuteri were observed.
"Possible mechanisms of the action of L reuteri include an improvement in gut motility and function and direct effects on visceral pain, both of which may induce a calming effect and reduced crying in infants," the authors write.
They address the fact that infants assigned to the placebo group of the study also had reduced crying time by day 21. They suggest that this response could be a result of the mother's cow's-milk-free diet or of physiologic maturation that ultimately resolves colic during normal development.
The authors note that they recently reported a higher prevalence of coliform bacteria, particularly E coli, in colicky infants compared with healthy counterparts. The present finding, that fecal E coli levels were significantly reduced with L reuteri supplementation, but not with placebo, suggests that L reuteri promotes gut health through a reduction of E coli colonization, they write.
"Administration of L reuteri DSM 17 938 to colicky infants is well tolerated and improves symptoms of infantile colic compared with placebo, and this effect may be related to induced changes in the fecal microbiota, particularly E coli," they conclude. "These findings provide important insights into the role of an aberrant bacterial flora in the pathogenesis of infantile colic and the potential to overcome this with probiotic supplementation."
The study was supported by BioGaia AB. The study authors have disclosed no relevant financial relationships.
Pediatrics. Published online August 16, 2010.