Oral Probiotic Containing Streptococcus salivarius K12 and Lactobacillus brevis CD2 for Preventing Bacterial Pneumonia in Severe COVID-19: Randomized Clinical Trial.
- 2025-11-12
- The journal of contemporary dental practice 26(10)
- Jonathan R Lauxen
- Sidia M Callegari-Jacques
- Augusto S Mombelli
- Amanda Prando
- Tiago T Simon
- Fernando Fornari
- PubMed: 41526312
- DOI: 10.5005/jp-journals-10024-3954
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 60
- Population
- 60 patients with severe COVID-19
- Methods
- randomized, placebo-controlled trial, 7-day course of oral gel containing S. salivarius K12 (2 billion CFU) and L. brevis CD2 (4 billion CFU) every 8 hours, or placebo, starting on the first ICU day; gel applications performed by a dentist
- Blinding
- Double-blind
- Duration
- 7 days
- Funding
- Unclear
Aims
To assess the effect of dental application of oral probiotics containing Streptococcus salivarius K12 and Lactobacillus brevis CD2 on preventing secondary bacterial pneumonia in patients with severe COVID-19.Materials and methods
In this randomized, placebo-controlled trial, 60 patients with severe COVID-19 were randomly assigned to receive a 7-day course of oral gel containing S. salivarius K12 (2 billion colony-forming units) and L. brevis CD2 (4 billion colony-forming units) every 8 hours, or placebo, starting on the first intensive care unit (ICU) day. Gel applications were performed by a dentist. The primary outcome was bacterial pneumonia, whereas the secondary outcomes were survival and the 14-day illness-severity status.Results
Fifty patients completed the 7-day experiment. In which, 26 patients received probiotics (mean age: 58.7 years old, 81% men) and 24 patients received a placebo (60.5 years old, 71% men). The incidence of secondary bacterial pneumonia was 35% for probiotics and 54% for placebo [relative risk: 0.64 (95% CI: 0.34-1.22)]. Compared with placebo, patients treated with probiotics showed similar rates of ICU death [hazard ratio: 1.37 (95% CI: 0.56-3.35)]. The 14-day illness-severity status did not differ between groups.Conclusion
In this phase II trial of patients with severe COVID-19, oral probiotics containing S. salivarius K12 and L. brevis CD2 did not prevent secondary bacterial pneumonia.Clinical significance
Intensive care unit patients with COVID-19 are prone to secondary bacterial pneumonia. Probiotics against oral pathogens might prevent lung colonization and avoid pneumonia. How to cite this article: Lauxen JR, Callegari-Jacques SM, Mombelli AS, et al. Oral Probiotic Containing Streptococcus salivarius K12 and Lactobacillus brevis CD2 for Preventing Bacterial Pneumonia in Severe COVID-19: Randomized Clinical Trial. J Contemp Dent Pract 2025;26(10):931-937.Research Insights
The 14-day illness-severity status did not differ between groups.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2 billion colony-forming units every 8 hours
patients treated with probiotics showed similar rates of ICU death [hazard ratio: 1.37 (95% CI: 0.56-3.35)].
- Effect
- Neutral
- Effect size
- Moderate
- Dose
- 2 billion colony-forming units every 8 hours
The incidence of secondary bacterial pneumonia was 35% for probiotics and 54% for placebo [relative risk: 0.64 (95% CI: 0.34-1.22)].
- Effect
- Neutral
- Effect size
- Large
- Dose
- 2 billion colony-forming units every 8 hours