Multispecies probiotic may not reduce risk of antibiotic-associated diarrhoea in children: JAMA

The efficacy of multispecies probiotic formulations in the prevention of antibiotic-associated diarrhoea (AAD) remains unclear.

A study was conducted to assess the effect of a multispecies probiotic on the risk of antibiotic-associated diarrhoea in children.

This randomized, quadruple-blind, placebo-controlled trial was conducted from February 2018 to May 2021 in a multicenter, mixed setting (inpatients and outpatients). Patients were followed up throughout the intervention period. Eligibility criteria included age 3 months to 18 years, recruitment within 24 hours following initiation of broad-spectrum systemic antibiotics, and signed informed consent. In total, 646 eligible patients were approached and 350 patients took part in the trial.

A multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, L acidophilus W55, Lactocaseibacillus paracasei W20, Lactoplantibacillus plantarum W62, Lactocaseibacillus rhamnosus W71, and Ligilactobacillus salivarius W24, for a total dose of 10 billion colony-forming units daily, for the duration of antibiotic treatment and for 7 days after. The primary outcome was antibiotic-associated diarrhoea, defined as 3 or more loose or watery stools per day in a 24-hour period, caused either by Clostridioides difficile or of otherwise unexplained etiology, after testing for common diarrheal pathogens. The secondary outcomes included diarrhoea regardless of the etiology, diarrhoea duration, and predefined diarrhoea complications.

Results:

• A total of 350 children were randomized and 313 were included in the intention-to-treat analysis.
• Compared with placebo (n = 155), the probiotic (n = 158) had no effect on risk of antibiotic-associated diarrhoea
• However, children in the probiotic group had a lower risk of diarrhoea regardless of the etiology
• No differences were observed between the groups for most of the secondary outcomes, including adverse events.

A multispecies probiotic did not reduce the risk of antibiotic-associated diarrhoea in children when analyzed according to the most stringent definition. However, it reduced the overall risk of diarrhoea during and for 7 days after antibiotic treatment. Their study also shows that the antibiotic-associated diarrhoea definition has a significant effect on clinical trial results and their interpretation.

Reference:

Multispecies Probiotic for the Prevention of Antibiotic-Associated Diarrhea in Children A Randomized Clinical Trial by Jan Łukasik, et al. published in the JAMA Pediatrics

doi:10.1001/jamapediatrics.2022.1973