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October 23, 2014

Probiotics may significantly reduce colic in North American infants: Motherisk study

TORONTO – Babies cry. And as many new parents quickly learn, sometimes feeding, changing a diaper, adjusting the temperature or cuddling won’t make the wee one stop wailing. As days roll into weeks, baby’s excessive and inconsolable crying, with bouts of fussiness and passing gas, continues. Tired and frustrated parents scour the web and survey doctors and other parents, searching for something – anything – to end their baby’s discomfort due to infantile colic. The few available treatments have minimal impact on crying and fussing time.

New research led by the Motherisk Program at The Hospital for Sick Children (SickKids) shows for the first time that probiotics can significantly reduce colic in North American infants. The study assessed the effectiveness of Lactobacillius reuteri DSM 17938 in treating infantile colic in exclusively breastfed Canadian babies. The paper is published in the Oct. 23 advance online edition of The Journal of Pediatrics.

“Infantile colic is one of the major concerns of many parents of babies, and for a long time, doctors and parents alike have struggled with a lack of treatment options to ease colic symptoms in early infancy,” says Dr. Gideon Koren, Founding Director of Motherisk and Senior Scientist at SickKids. “It is critical to evaluate natural products, such as probiotics, with the same scientific rigour used for medicinal drugs. Using these rigorous methods, we have shown that this probiotic can help infants.”

An estimated five to 40 per cent of infants experience colic, typically beginning around six weeks of age, and ending at about three or four months. Babies with colic usually fuss at least three hours a day, more than three days in a week over at least three weeks, with no obvious trigger.

While recognized by the medical community for centuries, the cause of infantile colic remains unknown, with theories ranging from overproduction of intestinal gas to insecure parental attachment. Some research has pointed to a potential role of the intestinal microbiota, microorganisms that include “good bacteria”, which differ greatly between infants with colic and those without. Some babies with colic have also been shown to have inadequate levels of a type of good bacteria (probiotic) called lactobacilli in early infancy.

Growing evidence suggests that probiotic supplements, which introduce live microorganisms into the gut, can regulate intestinal bacteria patterns and suppress inflammation. Clinical trials from Europe and Australia have previously assessed the probiotic L reuteri DSM 17938 in infants with colic, with inconsistent results.

“There is evidence that in different parts of the world, gut bacteria differ substantially, which means a treatment that worked overseas may not be effective for infants here in North America,” Koren explains. “This is why it was important to assess the probiotic’s effect on the specific microbiota of North American babies.”

To assess the effectiveness of the probiotic L reuteri DSM 17938, the research team conducted a randomized, double-blind, placebo-controlled trial from February 2012 to April 2014 at SickKids and in paediatric clinics in Toronto. For 21 days, 52 babies were given a five-drop dose, once per day at the same time of day. Parents or caregivers were asked to refrain from other modes of medications for consoling the baby.

At the outset of the study, the general characteristics between the probiotic group and the placebo group were similar. The median crying and fussing time for both groups was also comparable: 131 minutes per day for the probiotic group and 122 minutes per day for the placebo group. At the end of the treatment period, the probiotic group exhibited a significantly shorter duration of crying and fussing (60 minutes per day), versus the placebo group (102 minutes per day). More than half of the probiotic group had experienced a reduction in colic symptoms by the end of the study period, with some babies showing a statistically significant improvement as early as seven days after beginning treatment. The probiotic was well tolerated, and no side-effects were reported in either group.

Koren is Professor of Paediatrics, Pharmacology, Pharmacy and Medical Genetics at the University of Toronto. The study is a collaboration with the University of Toronto and St. Joseph’s Health Care in Toronto.

The research was funded by The Research Leadership for Better Pharmacotherapy During Pregnancy and Breastfeeding, and SickKids Foundation.

About The Hospital for Sick Children

The Hospital for Sick Children (SickKids) is recognized as one of the world’s foremost paediatric health-care institutions and is Canada’s leading centre dedicated to advancing children’s health through the integration of patient care, research and education. Founded in 1875 and affiliated with the University of Toronto, SickKids is one of Canada’s most research-intensive hospitals and has generated discoveries that have helped children globally.  Its mission is to provide the best in complex and specialized family-centred care; pioneer scientific and clinical advancements; share expertise; foster an academic environment that nurtures health-care professionals; and champion an accessible, comprehensive and sustainable child health system. SickKids is proud of its vision for Healthier Children. A Better World. For more information, please visit www.sickkids.ca.


For more information, please contact:

Suzanne Gold
The Hospital for Sick Children
416-813-7654, ext. 202059

Matet Nebres
The Hospital for Sick Children