Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19

NCT05175833 | Completed Phase 2

• 1 other identifier: CONEP 4.240.135
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Secondary bacterial pneumonia

  In patients with severe COVID-19 managed in ICU, the occurrence of symptoms and signs of secondary bacterial pneumonia

  From date of randomization until the date of first documented secondary bacterial pneumonia or date of death from any cause, whichever came first, assessed up to 90 days.

Secondary Outcomes (2)

• ICU stay

  up to 90 days

• hospital mortality

  up to 90 days

Study Arms (2)

Oral probiotics

EXPERIMENTAL

oral gel containing Streptococcus salivarius K12 (2 billion live bacilli) and Lactobacillus brevis CD2 (4 billion live bacilli). During the trial, the oral gel was applied in the mouth every 8 hours for 7 days

Combination Product: Oral probiotics

Oral placebo

PLACEBO COMPARATOR

oral gel containing placebo. During the trial, the oral gel was applied in the mouth every 8 hours for 7 days

Other: Oral placebo

Interventions

Oral probiotics COMBINATION_PRODUCT

Oral gel containing streptococcus salivarius K12 and lactobacillus brevis CD2

Oral probiotics

Oral placebo OTHER

Oral gel containing placebo

Oral placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalized in the ICU with severe acute respiratory syndrome
• progressive deterioration of the ventilatory status in the first 48 hours in the ICU, which may require mechanical ventilation within this period;
• confirmed diagnosis of COVID-19 within 3 days of ICU admission;
• acceptance to participate.

You may not qualify if:

• relevant immunodeficiency (decompensated HIV, aggressive immunosuppression, terminal cancer)
• decompensated systemic disease before the onset of COVID-19.

Sponsors & Collaborators

• Universidade de Passo Fundo: lead

Study Sites (1)

University of Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010080, Brazil

Location

MeSH Terms

Conditions

Communicable Diseases; COVID-19

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pedro Corazza, PhD

  PostGraduate Program in Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Oral probiotics and placebo were physically identical and were revealed after statistical analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized trial of oral probiotics versus placebo

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 4, 2022
• Study Start: September 11, 2020
• Primary Completion: January 25, 2021
• Study Completion: February 7, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

BR (1)