A probiotic containing L. plantarum and P. acidilactici strains for treating upper respiratory infection in children aged 6 months to 5 years: a randomized, double-blind trial
et al., European Journal of Pediatrics, doi:10.1007/s00431-025-06587-7, ISRCTN-66122782, Nov 2025
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RCT 75 pediatric outpatients (6 months to 5 years) with specialist-diagnosed upper respiratory infections with pharyngitis, showing reduced duration of fever and pain/discomfort with a probiotic formula containing L. plantarum KABP022, KABP023, KABP033 and P. acidilactici KABP021, compared to placebo.
Probiotic efficacy depends on the specific strains used. Specific microbes may decrease or increase COVID-19 risk1.
Andrade-Platas et al., 26 Nov 2025, Double Blind Randomized Controlled Trial, placebo-controlled, Mexico, peer-reviewed, median age 15.0, 5 authors, study period October 2022 - February 2023, trial ISRCTN-66122782.
Contact: espadaler@ab-biotics.com.
Abstract: ## RESEARCH
A probiotic containing L. plantarum and P. acidilactici strains for treating upper respiratory infection in children aged 6 months to 5 years: a randomized, double-blind trial
D. Andrade-Platas 1
· M. G. Martinez-Figueroa
- J. Espadaler-Mazo 2,3
Received: 25 July 2025 / Revised: 29 September 2025 / Accepted: 18 October 2025 © The Author(s) 2025 / Published online: 26 November 2025
Abstract
Upper respiratory infections (URIs) are highly prevalent, especially among young children. We aimed to investigate the efficacy and safety of a specific probiotic formula in shortening the duration of pediatric URIs of likely viral origin. A randomized, double-blind clinical trial was conducted in children aged 6 months to 5 years, with URI with pharyngitis as diagnosed by a specialist. Participants were allocated to probiotic (strains L. plantarum KABP022, KABP023, and KABP033 and P. acidilactici KABP021) or placebo, twice daily for 15 days, and further followed up at 30 and 60 days from baseline. Antipyretic (ibuprofen) and antihistamine (cetirizine) were allowed as comedication and controlled. Co-primary outcomes were days of fever (axillary temperature > 37.5 °C) and days of pain/discomfort (Face, Legs, Activity, Cry, and Consolability [FLACC] score > 3), as recorded in a diary. Causative viruses were identified by PCR in nasopharyngeal swabs. Seventy-five children were randomized and included in the analysis. The most frequent causative agents were rhinoviruses, coronaviruses, and respiratory syncytial virus. Compared to placebo, the durations of fever and of pain/discomfort were reduced by 1.1 days (95% CI 0.5-1.7; p = 0.001) and by 0.7 days (95% CI 0.2-1.2; p = 0.006) in the probiotic group, respectively. Sensitivity analyses by detected virus, age, sex, and recent URI episodes produced similar results. The use of comedication and other symptoms did not differ between study groups. No significant differences were found in the number of adverse events between the groups.
Conclusion : Intervention with this probiotic formula was associated with a shorter duration of fever and pain/discomfort in pediatric URIs with pharyngitis.
Trial registration: Prospectively registered on Oct 5 th , 2023, as ISRCTN-66122782.
What is Known:
- Acute upper respiratory tract infections (URIs) are highly prevalent in children, but due to their frequent viral etiology, treatment is often symptomatic only. Some probiotics have shown promising results against URIs, but evidence mostly relies on untrained, subjective diagnosis by participants or their parents. Recently, a probiotic formula containing strains L. plantarum KABP022, KABP023, and KABP033 and P. acidilactici KABP021 reduced viral load and duration of symptoms in a randomized trial in 300 adults with laboratory-confirmed Covid19, against placebo.
What is New:
- In children with URI with pharyngitis, as diagnosed by a specialist, intervention with said probiotic formula reduced the duration both of fever and of pain/discomfort, compared to placebo. Results were robust to sensitivity analyses by age, sex, number of recent URIs, and by most prevalent causative viruses in the study population.
Communicated by Tobias Tenenbaum
* J. Espadaler-Mazo espadaler@ab-biotics.com
1 Service of Pediatrics, Hospital Medica Sur, Mexico City, Mexico
- 2 R&D Department, AB-Biotics SA (Kaneka Group), Barcelona, Spain
- 3 Basic Sciences Department, Universitat Internacional de..
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