drugset / Trial / NCT05175833

Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19

NCT05175833 ↗

Phase 2 Completed 70 enrolled Universidade de Passo Fundo
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Background and aims: Patients with severe Coronavirus Disease 2019 (COVID-19) are prone to secondary bacterial pneumonia. The use of probiotics against oral pathogens might prevent lung colonization and progression to bacterial pneumonia. This study aimed to assess the effect of Streptococcus salivarius K12 combined with Lactobacillus brevis CD2 in preventing secondary bacterial pneumonia in patients with severe COVID-19. Methods: This randomized placebo-controlled phase 2 trial involved 70 patients with severe COVID-19 admitted to the intensive care unit (ICU). Patients were randomly assigned to a 7-day course of oral gel containing Streptococcus salivarius K12 2 billion colony-forming units (CFU) and Lactobacillus brevis CD2 4 billion CFU every 8 hours or placebo, starting in the first ICU day. The primary outcome was bacterial pneumonia, established according to clinical, laboratory, radiological, and microbiological findings, whereas secondary outcomes were ICU stay in days and hospital mortality.

Timeline

Start
2020-09-11
Primary completion
2021-01-25
Completion
2021-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus brevis CD2 Other / unclassified 4e+09 unknown Oral
Subject Streptococcus salivarius K12 Unknown 2e+09 unknown Oral