Prophylactic Probiotics Reduce Infantile Colic and Reflux

Lara C. Pullen, PhD

January 14, 2014

Treatment with the probiotic Lactobacillus reuteri DSM 17938 during the first 3 months of life reduced the likelihood of colic, regurgitation, and functional constipation. Prophylactic treatment also reduced the public and private costs of managing these conditions.

Flavia Indrio, MD, from University of Bari Aldo Moro, Italy, and colleagues published the results of their large randomized clinical trial online January 13 in JAMA Pediatrics. The cohort included 589 newborns born at 9 neonatal units in Italy between September 1, 2010, and October 30, 2012. The investigators included both breast-fed and formula-fed infants.

The investigators report that daily administration of the probiotic reduced the incidence of inconsolable crying (mean duration of crying time, 38 vs 71 minutes; P < .01). In addition, infants in the probiotic group regurgitated significantly less often at 3 months of age as those in the control group (2.9 vs 4.6 times per day; P <.01).

The authors note that 16.8% of the study population was lost to follow-up.

Infantile colic is common and tends to peak at approximately 6 weeks of age. It is the cause of 10% to 20% of all pediatrician visits during the first 4 months of life. The authors found the use of the probiotic drops to be cost-effective (mean savings of $118.71 per patient for the family and mean savings of $140.30 per patient for the community).

Neonatal colic is considered a self-limiting clinical condition of unknown etiology. Numerous studies have suggested, however, that early functional gastrointestinal disorders can predict different diseases later in life. For example, the research group in Italy has previously published that children diagnosed with irritable bowel syndrome had a higher percentage of neonatal functional gastrointestinal disorders than those without irritable bowel syndrome.

Although the mechanism behind the connection between neonatal colic and later diseases is not clear, the authors suggest that early pain may promote the development of long-term visceral hypersensitivity and mucosal permeability. This could then alter the balance of the enteric microflora and increase low-grade inflammation. The authors propose that prophylactic treatment with lactobacilli may drive a change in colonization that may promote an improvement in intestinal permeability.

Long-term follow-up of infants treated with probiotics should shed some light on the effect of the treatment on long-term health.

At this time, systematic reviews and meta-analyses do not support the general use of probiotics in all infants with colic. Moreover, the mechanism of action behind the benefits of probiotics is still unclear.

"Nonetheless, despite their lack of information about the mechanisms of action and some study limitations, Indrio et al lend additional support to the potential use of L. reuteri DSM 17938 for infantile colic. Perhaps there will come a time when medical providers will recommend 5 probiotic drops a day to keep infantile colic away," write Bruno P. Chumpitazi, MD, MPH, and Robert J. Shulman, MD, from Baylor College of Medicine in Houston, Texas, in an accompanying editorial.

Dr. Chumpitazi and Dr. Shulman also note that, to date, there have been no documented adverse events in the use of probiotics for the treatment of infantile colic.

Caution is still warranted, Elizabeth Marcus, MD, assistant professor in the Department of Pediatrics, Division of Pediatric Gastroenterology, Hepatology, and Nutrition in Mattel Children's Hospital, University of California, Los Angeles, said to Medscape Medical News. "[T]reating every infant with probiotics as a prophylactic measure would be a dramatic step and not without risk. It would be interesting to see if probiotics could have similar efficacy as a treatment measure targeted only toward infants who show symptoms of specific conditions. This would be a finding that could potentially change clinical practice."

The study was supported by BioGaia AB, Sweden, which provided active study product and placebo. Dr. Shulman serves as a consultant for Mead Johnson & Co, LLC. Dr. Chumpitazi and Dr. Marcus have disclosed no relevant financial relationships.

JAMA Pediatr. Published online January 13, 2014. Article full text, Editorial full text

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