- A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
- Probiotics have emerged as a new potential approach to managing infectious diseases.
- Adverse events were mild, and did not significantly differ between the two groups.
A probiotic mixture reduced fever duration among young children with upper respiratory tract infections (URTIs), a placebo-controlled trial from Italy showed.
Among 128 children treated at a pediatric emergency department, the median fever duration was 3 days in the probiotic group compared with 5 days in the placebo group (adjusted risk ratio 0.64, 95% CI 0.51-0.80), reported Carlo Agostoni, MD, of the Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico and the University of Milan, and colleagues.
Adverse events, including constipation and abdominal pain, were mild, and did not significantly differ between the two groups, they noted in JAMA Network Open.
Fever is common in patients with URTIs and has a “substantial impact on the child’s well-being as well as on physical and scholastic activities,” Agostoni and colleagues wrote. “Moreover, it is a potential source of concern for both physicians and caregivers and is associated with an increased, and sometimes inappropriate, use of antibiotics.”
“In past decades, the administration of probiotics has emerged as a new potential approach to managing infectious diseases,” they added. “The most widespread application of these supplements has been the mitigation of gastrointestinal symptoms. However, the interplay between gut microbiome, inflammatory processes, and immune response suggests the possible role of probiotics in infectious conditions not limited to the gastrointestinal tract.”
Probiotics’ potential effects beyond the gut were also observed in a study that suggested a link to decreased mortality in preterm infants.
For this study conducted from November 2021 to June 2023, Agostoni and colleagues included 128 children ages 28 days to 4 years with a fever (≥38.5 °C). Mean age was 2.5 years, 54% were boys, 79% were white, and 10% were Hispanic. Of these kids, 26% were receiving antibiotics at enrollment.
The probiotic group received a daily single dose of 0.5 mL of the probiotic mixture, which contained Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001, for 14 days, while the control group received a daily single dose of 0.5 mL placebo for the same duration.
Over half of the patients (55%) fully adhered to the protocol, 13% partially adhered to the protocol, and 32% dropped out of the trial.
Among patients receiving antibiotics at enrollment, none in the probiotic group and three in the control group developed diarrhea. For patients discharged without any antibiotics, 2% in the probiotic group and 12% in the control group were prescribed antibiotics during follow-up visits after emergency department discharge (P=0.16).
Agostoni and colleagues noted that they did not investigate specific infectious diseases (such as influenza) or differentiate between bacterial and viral infections, which was a limitation to the study. In addition, the diagnosis of URTI and antibiotic prescription were not standardized.
Furthermore, caregivers measured temperature at home without supervision, and the trial was conducted at a single emergency department.
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Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.
Disclosures
The study was funded in part by the Italian Ministry of Health and by an unrestricted grant to the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico from Coree Srl.
Agostoni reported receiving consulting fees from Coree Srl.
Co-authors reported relationships with Coree Srl, Angelini Pharma SPA, and Reckitt Benckiser Healthcare SPA.
Primary Source
JAMA Network Open
Source Reference: Bettocchi S, et al “Probiotics and fever duration in children with upper respiratory tract infections: a randomized clinical trial” JAMA Netw Open 2025; DOI: 10.1001/jamanetworkopen.2025.0669.
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