Combined probiotic formulation of no benefit to children with gastroenteritis
Twice-daily administration of a combined Lactobacillus rhamnosus and Lactobacillus helveticus probiotic in children with gastroenteritis fails to prevent the development of moderate-to-severe gastroenteritis within 2 weeks after presentation, as shown in a recent study.
Researchers randomized 886 babies with gastroenteritis aged 3–48 months to receive a 5-day course of a combination probiotic product containing L. rhamnosus R0011 and L. helveticus R0052 at a dose of 4.0×109 colony-forming units twice daily (n=444) or placebo (n=442), among whom 414 and 413, respectively, completed follow-up.
The primary outcome of incident moderate-to-severe gastroenteritis – defined according to a postenrolment modified Vesikari scale symptom score of ≥9 – within 14 days after enrolment was similar in the probiotics and placebo groups (26.1 percent vs 24.7 percent, respectively; odds ratio [OR], 1.06; 95 percent CI, 0.77–1.46; p=0.72).
Multivariable logistic regression analysis showed no significant association between treatment and the risk of developing moderate-to-severe gastroenteritis (OR, 1.06; 0.76–1.49; p=0.74).
Furthermore, there were no significant differences seen between the probiotic and placebo groups in terms of the median duration of diarrhoea (52.5 vs 55.5 hours; p=0.31) or vomiting (17.7 vs 18.7 hours; p=0.18), the percentage of children with unscheduled visits to a health care provider (30.2 percent vs 26.6 percent; OR, 1.19; 0.87–1.62; p=0.27), and the percentage of those who had an adverse event (34.8 percent vs 38.7 percent; OR, 0.83; 0.62–1.11; p=0.21).
The present data suggest that the combined probiotic formulation is not effective in preventing moderate-to-severe gastroenteritis within 14 days in infants and young children presenting with symptoms of gastroenteritis for up to 72 hours and have been brought for care in the emergency department, researchers said.