|Administration of probiotics does not show benefit in kids with acute gastroenteritis|
|Probiotics are widely prescribed to those with gastrointestinal disorders among other indications, although the evidence supporting this strategy remains lacking. In this week’s NEJM, two independent articles indicate that administration of probiotics in children with acute gastroenteritis has not shown benefit. It is the time to reconsider the rational to supply probiotics.
In the trial led by Dr. David Schnadower (here), 943 children aged between 3 months and 4 years in the US were analyzed, among whom 468 were randomly assigned to receive Lactobacillus rhamnosus GG and 475 were assigned to receive placebo. Participants received Lactobacillus rhamnosus GG or placebo twice daily for 5 days. The primary outcome was the presence of moderate-to-severe gastroenteritis during the 14-day follow-up period after randomization. There was no difference in the ratio of children with moderate-to-severe gastroenteritis during the 14-day follow-up period between groups (11.8% in the Lactobacillus rhamnosus group v.s. 12.6% in the placebo group). No differences were observed between groups in terms of the frequency or duration of diarrhea or vomiting, unscheduled clinic visits for symptoms of gastroenteritis or their complications, among others. The adverse event rates were similar between groups.
In another trial conducted by Dr. Stephen Freedman (here), 827 children with acute gastroenteritis aged between 3 month and 48 months in Canada were enrolled. A total of 414 children were randomly assigned to receive a probiotic product containing Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052, whereas 413 children were assigned to the placebo group. Probiotic or placebo was administered twice daily for 5 days. The primary endpoint was occurrence of moderate-to-server gastroenteritis during the first 14 days after enrollment. The rate of kids with moderate-to-severe gastroenteritis within 14 days after randomization was 26.1%, which was similar to that of the placebo group (24.7%). No differences between the groups existed in the median duration of diarrhea or vomiting, the ratio of kids that had unscheduled clinic visits, or the ratio of adverse events.
Both of the above trials, which were conducted in North American involving similar populations, failed to show benefit of probiotics in pediatric patients with acute gastroenteritis. Recent studies also indicated orally administered probiotics resist to colonize in the intestinal mucosa of human participants (Zmora, et al. Cell. 2018, here), indicating the poor efficiency of orally supplied probiotics. Probably, it is time to reconsider the rationale of probiotic administration, and more personalized approaches are needed if probiotics indeed harbor beneficial influence on human.