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Investigators from multiple institutions conducted a randomized controlled trial to assess the efficacy of a multispecies probiotic mixture in preventing antibiotic-associated diarrhea (AAD) in children. Study participants were patients 3 months to 18 years old who were enrolled within 24 hours following initiation of oral or intravenous broad-spectrum antibiotics in the pediatric clinical or outpatient wards of 3 Dutch and 2 Polish hospitals. The enrolled children were randomized to receive the probiotic mixture, containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, L. acidophilus W55, Lacticaseibacillus paracaseri W20, Lactiplantibacillus plantarum W62, Lacticaseibacillus rhamnosus W71, and Ligilactobacillus salivarius W24 (total dose 5 billion CFU) twice daily for the duration of antibiotic administration and for 7 additional days, up to a maximum of 17 days, or placebo. Study diaries were used to record the consistency of stools, and diarrhea was defined as 3 or more loose or watery stools in 24 hours. Samples of diarrheal stools were tested for Clostridiodes difficile, rotavirus, adenovirus, norovirus, Campylobacter species, Salmonella species, Shigella species, and Yersinia species. The primary outcome was AAD, defined as diarrhea caused by C. difficile or otherwise of unknown etiology. Secondary outcomes included diarrhea of all causes (known and unknown), need for IV rehydration because of diarrhea, diarrhea due to C. difficile, and hospitalization because of diarrhea. Differences in these outcomes were compared among children in the probiotic and treatment groups by calculating relative risks (RR) and 95% confidence intervals (CI).
A total of 350 patients with a median age of 28 months were enrolled. Among these participants, 77.4% were inpatients, and 22.6% were seen in outpatient settings. The most-commonly used antibiotics were aminopenicillin (prescribed to 40% of participants) and amoxicillin and clavulanic acid (prescribed to 34.9%). The characteristics of children in the 2 treatment groups were similar. Data on the outcomes were analyzed on 313 patients, including 158 randomized to probiotics and 155 who received placebo. There was no statistically significant difference in rates of AAD in patients in the 2 treatment groups. Among those in the probiotic group, 23 (14.6%) developed AAD, compared to 28 (18.1%) of those randomized to placebo (RR, 0.81; 95% CI, 0.49, 1.33). However, diarrhea of all causes was significantly less frequent in participants receiving probiotics than in placebo recipients (rates, 20.9% and 32.3%; RR, 0.65; 95% CI, 0.44, 0.94). In addition, no patients in the probiotic group required IV therapy for rehydration because of diarrhea vs 5 (3.2%) of those receiving placebo. There were no significant differences between treatment groups in occurrence of diarrhea due to C. difficile (1 participant in probiotic group and 3 randomized to placebo) or hospitalization for diarrhea (1 and 2 children, respectively, from the probiotic and placebo groups).
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