
The results of a small randomized controlled trial in Italy suggest that probiotics may be helpful in treatment of children with upper respiratory tract infections (URTIs), Italian researchers reported today in JAMA Network Open.
Conducted in the pediatric emergency unit of a hospital in Milan, the trial involved 128 children (ages 28 days to 4 years) who presented with a fever and URTI at some point from November 19, 2021, to June 20, 2023. The children were randomized 1:1 to receive a daily single dose of a commercially available probiotic mixture containing Bifidobacterium breve, Bifidobacterium lactis, and Lactobacillus rhamnosus or a daily dose of placebo for 14 days. The primary outcome was fever duration.
Of the 128 children enrolled (54% male; mean age, 2.5 years), 65 received the probiotic mixture and 63 received placebo. Thirty-three patients were receiving antibiotics at enrollment.
Fever duration reduced by 2 days
The median fever duration was 2 days shorter in the probiotic group than in the placebo group (3 days vs 5 days; adjusted risk ratio, 0.64; 95% confidence interval [CI], 0.51 to 0.80). Reported adverse events included diarrhea (4 cases), constipation (12), and abdominal pain (5). The distribution of adverse events did not differ significantly between the probiotic and placebo groups.
“The probiotic mixture under investigation could be an effective adjuvant for shortening fever duration in children with URTIs,” the study authors concluded.
The authors say the findings align with growing evidence on the immunomodulatory effects of probiotics, including studies showing that probiotics can enhance humoral immunity, can increase the production of antibodies, and demonstrate activity against prevalent respiratory viruses.
"These mechanisms may partly explain the significant reduction in fever duration observed in this trial," they wrote.