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Infant colic affects approximately 20% of babies up to 3 months of age. Recent research has focused on probiotics as a means of treating infant colic, and so far has had contradictory results. While earlier studies demonstrated positive effects from probiotic supplements, a recent, larger clinical trial has reported no difference in symptoms when giving supplements of Lactobacillus reuteri for infants with colic. While there is not yet any definitive proof that probiotic supplements are beneficial for babies with colic, there are more clinical trials currently underway investigating their potential.

As defined by Wessel’s criteria, colic is excessive crying in a healthy baby for at least three hours per day, three days per week, for three weeks. Colic is the primary reason for visits to healthcare facilities in infants up to three months old. In addition, secondary effects of a baby with colic include: maternal depression, less time spent breastfeeding, and shaken baby syndrome.

While the cause of colic remains unclear, there are several hypotheses. One hypothesis is gastrointestinal complications such as intra-abdominal gas, hyperperistalsis, visceral pain, and inflammation of the gut. This has led to the investigation of probiotic supplements as a treatment strategy. The basis for the use of probiotics comes from studies that have reported an increase in the amount of gas forming organisms in the gut of infants suffering from colic. Therefore, probiotic supplements would potentially increase beneficial bacteria in the gut, thereby reducing the amount of gas forming bacteria and the resultant negative effects. In this way, probiotic supplements may offer a protective effect against colic.

There have been three small clinical trials reporting beneficial effects of the probiotic Lactobacillus reuteri for infants with colic, who were exclusively breastfed. The trials reported that supplementation resulted in reduced crying time of infants following treatment. Recently, the largest randomized, double blind clinical trial to date was conducted at the Royal Children’s Hospital in Melbourne, Australia. The trial included 167 infants less than three months old, meeting Wessel’s criteria, who were randomized to either a treatment group or placebo group. The infants in the treatment group were given L. reuteri DSM 17938 (0.2×108 colony forming units per drop) in an oil suspension, administered once a day for one month. The infants were assessed at days 7, 14, and 21 for crying, fussing, and sleep duration. In this study there was no difference observed in crying, fussing, infant sleep, maternal mental health, family or infant function, or quality of life when comparing the supplement versus the non-supplemented group. There was also no difference when analyzing the results of either breast fed infants only, or formula fed infants only. There was also no change observed in the fecal microbial profile, or calprotectin levels.

While the results of this study are contradictory to the previous three studies, there are currently three clinical trials underway to assess the effectiveness of L. reuteri in infant colic. One trial being conducted at the Hospital for Sick Children in Toronto, Canada will also assess the effects ofL. reuteri DSM 17938 infant drops. The study will include healthy term infants displaying symptoms of colic, between 21-90 days old, who weigh ≥2500g and are exclusively breastfed. The babies involved in the study will take 5 drops of the supplement, once daily, for 21 days, or placebo drops containing no probiotics. The study will assess the effect of the supplement on daily median crying time at 7, 14, and 21 days. In addition, parental quality of life, and reduction in number of infant crying episodes will be measured.

Another study is currently being conducted at the University of Texas Health Sciences Centre in Houston, United States. In this study, 45 healthy infants displaying symptoms of colic will be randomized to an L. reuteri treatment group, or a placebo group. The treatment group will receive L. reuteri drops orally, once per day, for 42 days. This study will assess biomarkers of inflammation in infants with colic. Fecal calprotectin will be assessed as an indicator of anti-inflammatory effects in the intestine. In addition, changes in crying times and fussing will also be measured. This study will include both breast fed and formula fed infants who are 21-70 days old and cry or fuss for more than three hours a day, three times per week.

A third study is also underway in France, which will assess the effectiveness of L. ReuteriDSM17938 probiotic, twice daily, for 21 days, on 40 breastfed infants aged from 29-90 days old. The infants will be randomized to a treatment of oral L. reuteri or placebo. Assessment of daily crying time will be taken at days 7, 14, and 21. Average duration of crying will also be assessed at these time points, in addition to gastrointestinal symptoms including: constipation, diarrhea, and flatulence.

Sung, V, Hiscock, H, Tang, MLK, Mensah, FK, Nation, ML, Satzke, C, Heine, RG, Stock, A, Barr, RG, Wake, M. “Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial”BMJ 2014;348:g2107 “Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic”Available from: Accessed: May 6, 2014. “Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic (PROBIOC)”Available from: Accessed: May 6, 2014. “Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic”Available from: Accessed: May 6, 2014.

Image courtesy of David Castillo Dominici /


Written by Deborah Tallarigo, PhD


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