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Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19

NCT05175833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

  • COVID-19 Lower Respiratory Infection
  • Microbial Colonization
  • Severe COVID-19
  • Secondary Bacterial Pneumonia

Interventions

COMBINATION_PRODUCT

Oral probiotics

Oral gel containing streptococcus salivarius K12 and lactobacillus brevis CD2

OTHER

Oral placebo

Oral gel containing placebo

Sponsors & Collaborators

  • Universidade de Passo Fundo

    lead OTHER

Principal Investigators

  • Pedro Corazza, PhD · PostGraduate Program in Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175833 on ClinicalTrials.gov