Meta-analysis confirms probiotics’ pediatric safety and efficacy

ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.

“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.

The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.

^{Mitchel L. Zoler/Frontline Medical News}

Dr. Gordon Morris

“The pain score reductions we saw [with these two strains] could certainly have an impact. I think it matters clinically,” he explained. “Severity of pain is most important to patients.”

Both L. reuteri and L. rhamnosus GG have received “generally regarded as safe” designations from the Food and Drug Administration.

Based on these findings, “I don’t think we can justify, especially with these two main strains, any further basic efficacy studies,” Dr. Morris said. The primary focus for future clinical assessments of these probiotics should be long-term efficacy and safety and whether patients have rebound pain on withdrawal from probiotic use, he added.

The meta-analysis used studies that compared probiotics against placebo in children aged 4-18 years who received treatment for 4-16 weeks. The full analysis showed an average 0.57-unit reduction in pain scores across all 11 studies included, with an average 0.61-unit reduction using L. reuteri and an average 0.75-unit reduction using L. rhamnosus GG. All three between-group differences were statistically significant. Safety data came from eight of the included studies, and they collectively showed absolutely no safety difference between actively treated and control patients.

Dr. Morris noted that the mechanism by which probiotic bacilli relieve abdominal pain remains unclear, but suggested that both prokinetic and anti-inflammatory effects might be involved.

mzoler@frontlinemedcom.com

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