by Sarah Wickline
Staff Writer, MedPage Today
March 03, 2014

Preventive use of probiotics reduced crying, vomiting, constipation, and healthcare-related costs among infants in a placebo-controlled trial, researchers reported.

On average, infants who were given prophylactic probiotics (L reuteri, strain DSM 17938) for the first 90 days of life spent less time crying per day (38 versus 71 minutes, P<0.01), had fewer regurgitations (2.9 versus 4.6, P<0.01), and had less constipation (4.2 evacuations versus 3.6, P<0.01) compared with infants taking a placebo, according to Flavia Indrio, MD, of Aldo Moro University of Bari in Bari, Italy, and colleagues.

Indrio and colleagues estimated the overall cost savings, on average, to be $118.71 for each family and $140.30 for the community from the use of probiotics to prevent colic, gastroesophageal reflux, and constipation, they wrote in JAMA Pediatrics.

Adam Powell, PhD, a healthcare economist at Payer + Provider in Boston, Mass., told MedPage Today, “This study suggests that probiotic supplements can improve newborn health; in the process, enabling parents to avoid missing work and reducing healthcare utilization.”

“While the study provides evidence that oral supplementation with lactobacillus reuteri keeps babies healthier, the cost savings estimated in the study were determined in an Italian context and cannot be easily translated. If anything, it is likely an underestimate of the savings, as the cost of medical care tends to be higher in the U.S. than in Italy,” Powell said.

Ari Brown, MD, FAAP, a pediatrician at 411 Pediatrics in Austin, Texas, told MedPage Today, “This study lends further evidence to the growing body of studies showing that probiotics can be useful in infancy. My only reservation about the validity of this study is that it was funded by the company that manufactures L. reuteri.”

“Newborns are born with a “clean slate” when it comes to gut flora, and it takes time for the flora to populate the intestines to aid in digestion. So, it makes sense that babies may benefit from receiving probiotics until their own gut flora arrives,” Brown said.

“This study demonstrated significant improvement in duration of crying, number of regurgitations, and an increased number of stools. While the authors cite the cost savings for families who have babies who do not need medical care or intervention when the babies are taking L. reuteri, really the benefit is a happier baby and happier parents,” Brown added.

In an editorial also published in JAMA Pediatrics, Bruno P. Chumpitazi, MD, MPH, of Texas Children’s Hospital in Houston, Texas, wrote, “[Previous studies have shown that] 10 years later, these infants with colic become children who have an 11-fold increased risk for developing recurrent abdominal pain, as well as an increased risk for allergic diseases and psychological disorders.”

Chumpatiza suggests possible mechanisms of probiotic function, but that a better understanding is still needed: “Various mechanisms of action have been proposed for probiotics, including enhancing epithelial barrier function, increasing IgA production, modulating cytokine profiles, influencing T lymphocytes, influencing other gut microbes, and affecting the enteric nervous system, that may result in changes in motility, pain perception, and brain activity … [But] two critical areas are in need of investigation: the mechanisms of action and the effect on long-term health.”

For the study, 589 infants were randomized into a probiotic group to receive L. reuteri or a placebo for 90 days from 2010 to 2012 across nine neonatal units in Italy.

After 3 months, compared with infants in the control group, infants in the probiotic group:

• Went to the pediatrician less often (1.3 visits over the course of the study versus 2.3, P<0.05)
• Went to the emergency department less often (0.52 visits versus 1.78, P<0.05)
• Used stomach-soothing products like simethicone, cimetropium bromide, or herbal products less often (-46.1%, -67.9%, and -42.5% fewer infants, respectively, were given these products in the probiotic group compared with controls, P<0.05)

Parents of infants in the probiotic group missed fewer days of work compared with parents of infants in the control group (0.54 days versus 2.89 days, P<0.05).

No adverse events were reported.