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New research says probiotics do not help infant colic

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Lactobacillus reuteri did not reduce crying or fussing or improve sleep

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Colic is a term used to describe uncontrollable crying in an otherwise healthy baby. Although it spontaneously resolves three to four months after birth, its cause remains elusive and no single effective treatment exists.

Previous small trials suggest that the probiotic Lactobacillus reuteri effectively treats colic in breastfed infants. These studies, however, had limitations as they examined only a highly selective group of infants with colic. The effects of L reuteri on formula fed infants with colic are unknown.

In this new study researchers based in Australia and Canada set out to determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.

Participants included 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing. Between August 2011 and August 2012, participants were recruited from a range of services accessed by careers of newborn babies in Melbourne, Australia: the Royal Children’s Hospital emergency department, the Royal Children’s Hospital Unsettled Babies Clinic, Tweddle Child and Family Health Center (a mother-infant parenting center), two maternal child health centers (universal nurse health checks), and pediatricians at the Royal Children’s Hospital and in private practices. Families could also contact the study team to be involved.

At random 85 infants received a probiotic and 82 received a placebo. Outcomes included daily duration of crying or fussing at one month, sleep duration, mother's mental health, family and infant quality of life.

The results showed that at one month the probiotic group cried or fussed an adjusted mean of 49 minutes/day more than the placebo group. The probiotic group fussed significantly more than the placebo group at all-time points from day seven to one month. Although daily duration of cry or fuss decreased over the study period in both groups, the decline by 1 month was greater in the placebo group than probiotic group, with a mean difference in reduction of 46 minutes. At 6 months, the groups did not differ for duration of cry or fuss.

By one month 40% (27) of the probiotic group and 48% (29) of the placebo group showed at least a 50% reduction in duration of cry or fuss.

In their conclusion the researchers write “L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.”

The researchers point out that this is the largest randomized controlled trial of probiotic intervention in infants with colic to date.

They conclude that L reuteri treatment "did not reduce crying or fussing in infants with colic, nor was it effective in improving infant sleep, maternal mental health, family or infant functioning, or quality of life" and say "probiotics therefore cannot be routinely recommended for all infants with colic."

Further research is needed to identify which subgroups of infants with colic may benefit from probiotics, they add.

Dr. William E Bennett Jr, MD, Assistant Professor of Pediatrics at Indiana University School of Medicine, in an accompanying editorial writes “This represents the most definitive and well-designed study to date on this controversial topic.”

With such a dearth of good evidence, should we be treating infant colic at all, he asks? He points out that children with colic "incur no serious long term effects" from the disorder and symptoms "abate with time," whereas the potential harm associated with diagnostic testing and treatment of infants "is likely to surpass the harm from colic itself."

As the old adage goes "babies cry," he concludes. Parents and their babies "may be better served if we devote more resources to studying the interventions recommended long before the discovery of probiotics: reassurance, family social support, and the tincture of time."

This study appears in BMJ-British Medical Journal.

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