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Probiotic Drops Ease Colic

By Todd Neale, Staff Writer, MedPage Today
August 16, 2010

MedPage Today Action Points

Discuss with patients that probiotic drops containing Lactobacillus reuteri

administered to colicky infants may significantly reduce crying times.

Explain to patients that probiotic supplementation with Lactobacillus reuteri in

infants younger than 2 months was not associated with any significant adverse
events in this small study.

Review

Any parent with a colicky baby knows the incessant crying that colic can produce --
but use of probiotic drops may reduce the infant's wailing, according to a small
randomized trial.

The double-blinded and placebo-controlled study of 46 breastfed colicky infants found

those who received probiotic drops containing a strain of Lactobacillus cried
significantly less each day after three weeks compared with babies who got placebo
drops (median 35 versus 90 minutes a day, P=0.022), according to Francesco
Savino, MD, PhD, of the University of Turin in Italy, and colleagues.

Significantly fewer colicky infants in the probiotic group cried for longer than three
hours a day at the end of the study (four versus 12, P=0.009), the researchers
reported in the September issue of the journal Pediatrics.

Benefits of the probiotic drops may have come from modifications of gut microbiota,
particularly a reduction in Escherichia coli, they wrote in their paper.

"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," they wrote.

The probiotic used in the study was Lactobacillus reuteri DSM 17 938.

A previous study suggested a benefit from a similar Lactobacillus probiotic when

compared with simethicone, but the researchers received criticisms because the
study was not double-blinded and placebo-controlled.

So Savino and colleagues recruited 50 exclusively breastfed infants with colic for the
current study. They ranged in age from 2 to 16 weeks at baseline.

Colic was diagnosed if the babies had episodes of fussy crying lasting at least three
hours a day on at least three days in the week before enrollment.
Half were assigned to receive the probiotic (108 colony-forming units) and half were
assigned to placebo. Both were administered in five drops once a day 30 minutes
before the morning feeding.

Parents monitored daily crying time and adverse effects in a diary.

Data were collected for analysis from 46 infants; 4 of the infants in the placebo group
were excluded from the analysis because of fever in one, gastroesophageal reflux in
another baby, and parental failure to complete the diary in two others.

Daily crying times were similar in the two groups at baseline -- a median of 370
minutes in the probiotic group and 300 in the placebo group (P=0.127). There were
steady declines in both groups during three-week study.

Infants were considered responders if they had at least a 50% reduction in crying
time from baseline. There were significantly more responders in the probiotic group at
days seven, 14, and 21 (P<0.05 for all).

Among the intervention group, 96% were considered responders at 21 days. The
considerable number of responses seen among the placebo group (71%) "could be
elicited by the mother's cow's-milk-free diet ... or more likely by physiologic maturation
that ultimately resolves colic during normal development," the authors noted.

During the study, fecal analysis revealed a significant change in the gut microbiota of
the infants in the probiotic group only, including an increase in lactobacilli and a
reduction in E. coli and ammonia, an end-product of amino acid fermentation by
various bacterial species (P<0.05 for all).

The ammonia reduction "could be related to modification of bacterial enzyme activity

through the reduction of E. coli and other members of the gut microbiota," the
researchers wrote.

No between-group differences were seen in weight gain, stooling frequency, rates of

constipation or regurgitation, and no adverse events related to supplementation were
reported in either group.

The study was funded by BioGaia AB, which develops and sells probiotic products.

The authors reported that they had no conflicts of interest.

Primary source: Pediatrics

Source reference:
Savino F, et al "Lactobacillus reuteri DSM 17 938 in infantile colic: a randomized,
double-blind, placebo-controlled trial" Pediatrics 2010; DOI: 10.1542/peds.2010-0433.

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