NCT05175833

Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19

Completed Phase 2 Last updated 24 January 2022

What this trial tests

Phase 2 trial testing Oral probiotics in COVID-19 Lower Respiratory Infection in 70 participants. Completed in 7 February 2021.

Timeline

11 September 2020

Primary endpoint
25 January 2021

7 February 2021

Quick facts

Lead sponsor	Universidade de Passo Fundo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	70
Start date	11 September 2020
Primary completion	25 January 2021
Estimated completion	7 February 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Oral probiotics
• Oral placebo

Conditions studied

• COVID-19 Lower Respiratory Infection — all drugs for COVID-19 Lower Respiratory Infection →
• Microbial Colonization — all drugs for Microbial Colonization →
• Severe COVID-19 — all drugs for Severe COVID-19 →
• Secondary Bacterial Pneumonia — all drugs for Secondary Bacterial Pneumonia →

Sponsor

Universidade de Passo Fundo — full company profile →

Who can join

18 and older, any sex, with COVID-19 Lower Respiratory Infection or Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alterations in microbiota of patients with COVID-19: potential mechanisms and therapeutic interventions.
   Wang B, Zhang L, Wang Y, Dai T, et al · · 2022 · cited 124× · PMID 35487886 · DOI 10.1038/s41392-022-00986-0
2. Microbiota and COVID-19: Long-term and complex influencing factors.
   Gang J, Wang H, Xue X, Zhang S. · · 2022 · cited 35× · PMID 36033885 · DOI 10.3389/fmicb.2022.963488
3. The Influence of the Gut Microbiota on Host Health: A Focus on the Gut-Lung Axis and Therapeutic Approaches.
   Alswat AS. · · 2024 · cited 21× · PMID 39459579 · DOI 10.3390/life14101279
4. COVID-19 influenced gut dysbiosis, post-acute sequelae, immune regulation, and therapeutic regimens.
   Raj ST, Bruce AW, Anbalagan M, Srinivasan H, et al · · 2024 · cited 19× · PMID 38863829 · DOI 10.3389/fcimb.2024.1384939
5. Gut Microbiota and COVID-19: Potential Implications for Disease Severity.
   Rocchi G, Giovanetti M, Benedetti F, Borsetti A, et al · · 2022 · cited 19× · PMID 36145482 · DOI 10.3390/pathogens11091050
6. Probiotics in the Intensive Care Unit.
   Schuurman AR, Kullberg RFJ, Wiersinga WJ. · · 2022 · cited 13× · PMID 35203819 · DOI 10.3390/antibiotics11020217
7. COVID-19 and Gut Injury.
   Shen S, Gong M, Wang G, Dua K, et al · · 2022 · cited 12× · PMID 36297092 · DOI 10.3390/nu14204409