L. rhamnosus-L. helveticus combo has little impact on paediatric gastroenteritis

A twice-daily dose of a probiotic product containing Lactobacillus rhamnosus (L. rhamnosus) R0011 and Lactobacillus helveticus (L. helveticus) R0052 for 5 days did little to prevent subsequent moderate-to-severe gastroenteritis episodes in children visiting the emergency department (ED) for acute gastroenteritis, results of the PERC PROGUT* trial showed.

Researchers of this multicentre, double-blind trial randomized children aged 3–48 months who presented at one of six paediatric EDs in Canada with symptoms of gastroenteritis (≥3 episodes of watery stools over 24 hours, vomiting or diarrhoea for <72 hours, and diagnosis of an acute intestinal infection) to receive either a probiotic product containing L. rhamnosus R0011 and L. helveticus R0052 in a 95:5 ratio (4.0 x 10⁹ CFU**; n=440, median age 16 months, 55.2 percent male) or placebo (n=437, median age 15 months, 57.7 percent male) twice daily for 5 days. A positive stool test for rotavirus A infection was more common in patients assigned to probiotics than placebo (28.7 percent vs 19.9 percent), while norovirus GI or GII was present in 23.6 and 29.0 percent of patients in these respective groups.

The incidence of moderate-to-severe gastroenteritis within 2 weeks of enrolment was comparable between children who were assigned probiotics and placebo (26.1 percent vs 24.7 percent, odds ratio [OR], 1.06, 95 percent confidence interval [CI], 0.77–1.46; p=0.72). [N Engl J Med 2018;379:2015-2026]

Children who were assigned probiotics also had a similar duration of diarrhoea or vomiting compared with children who were assigned placebo (median, 52.5 vs 55.5 hours; p=0.31 [diarrhoea] and median, 17.7 vs 18.7 hours; p=0.18 [vomiting]). The number of diarrhoea episodes was comparable between probiotics and placebo recipients (incidence rate ratio [IRR], 0.98; p=0.78), though there more episodes of vomiting among probiotics than placebo recipients (IRR, 1.36; p<0.001).

Probiotics recipients also had a similar likelihood of unscheduled visits to a healthcare provider for symptoms such as diarrhoea, vomiting, fever, or dehydration as placebo recipients (30.2 percent vs 26.6 percent, OR, 1.19, 95 percent CI, 0.87–1.62; p=0.27) as well as a similar risk of experiencing adverse events (34.8 percent vs 38.7 percent, OR, 0.83, 95 percent CI, 0.62–1.11; p=0.21).

According to the authors, there is disparity in the guideline recommendations for use of probiotics for acute gastroenteritis in the paediatric population with certain groups such as the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and European Society for Pediatric Infectious Diseases advocating their use [J Pediatr Gastroenterol Nutr 2014;59:132-152] and others expressing hesitance at making recommendations due to lack of data. [https://www.nice.org.uk/guidance/cg84/chapter/2-Research-recommendations#other-therapies-probiotics]

“[We found that] in children who presented to the ED with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrolment,” the authors said.

They pointed out that the findings are specific to this probiotic combination and dose and as such, may not apply to other probiotic formulations, nor may they be generalizable to other populations with different “local host microbiomes and infectious pathogens”.