A randomized clinical trial has found that a specific probiotic mixture may reduce fever duration in pediatric patients with upper respiratory tract infections.
In the study, published in JAMA Network Open and conducted at a pediatric emergency department in Milan, Italy, researchers demonstrated that the administration of probiotics shortened fever duration by approximately 2 days compared with placebo.
The triple-blind, placebo-controlled trial enrolled 128 patients aged 28 days to 4 years who presented with fever (≥ 38.5°C) and upper respiratory tract infection (URTI). The participants were randomly assigned to receive either a daily dose of a probiotic mixture containing Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001, or matching placebo for 14 days.
The median (interquartile range [IQR]) fever duration was shorter in the probiotic group than the placebo group (median [IQR] = 3 [2–4] days vs 5 [4–6] days; adjusted risk ratio = 0.64, 95% confidence interval = 0.51–0.80). This finding remained consistent across both intention-to-treat and per-protocol analyses, even after adjusting for age, sex, and antibiotic use.
The study included 69 male patients (54%) and 59 female patients (46%), with a mean age of 2.5 years. At baseline, 26% (n = 33) of the patients were already receiving antibiotics. The trial experienced a dropout rate of approximately 32%, with 87 participants completing the study protocol.
Secondary outcomes showed that among patients receiving antibiotics at enrollment, none of those in the intervention group and 3 patients in the control group developed diarrhea. Additionally, among patients discharged without antibiotics, 2% (n = 1/46) of those in the probiotics group and 12% (n = 6/49) of those in the placebo group were prescribed antibiotics during follow-up (P = .16).
Safety monitoring revealed few adverse events, with no significant differences between the study groups. Reported side effects included constipation (n = 6 [16%] in the probiotic group; n = 6 [12%] in the placebo group; P = .80) and abdominal pain (n = 3 [8%]; n = 2 [4%]; P = .65).
The researchers proposed several potential mechanisms for the observed effect, noting: "several studies have shown that a probiotic mixture can enhance humoral immunity, especially the activity of macrophages and dendritic cells, and increase the production of antibodies." They also noted that the specific probiotics used in the study "can modulate the expressions of interleukin-1, interleukin-6, and tumor necrosis factor, which play a key role in the development of fever."
The study's limitations included the single-center design and lack of infectious agent identification.
"[A]dministering a probiotic mixture containing B breve M-16V, B lactis HN019, and L rhamnosus HN001 resulted in shorter fever duration by 2 days compared with placebo in [pediatric patients] with URTIs," the study authors concluded.
This study contributed to the limited but growing body of evidence regarding the therapeutic potential of probiotics for respiratory conditions in pediatric populations.
Disclosures can be found in the study.
