Study to Investigate the Treatment Benefits of Probiotic Streptococcus Salivarius K12 for Hospitalised Patients (Non-ICU) With COVID-19

Study to Investigate the Treatment Effect of Probiotic Streptococcus Salivarius K12 in Hospitalised Patients (Non-ICU) With COVID-19

This is a randomised, open-label and controlled clinical trial aimed to investigate the adjuvant treatment benefits of probiotic Streptococcus salivarius K12 in hospitalised mild-to-moderate patients with COVID-19 disease.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Standard of care; Dietary supplement: BLIS K12

Detailed Description

Boosting the immunity and maintaining a healthy and balanced microflora at oropharyngeal environment of people through probiotics supplementation has been proposed as a possible strategy to protect human host from respiratory tract infections. A slow-dissolved oropharyngeal probiotic formula containing S. salivarius K12 has been clinically demonstrated to improve the upper respiratory tract microbiota protecting the host from pathogenic bacteria, fungi, and viruses, thereby reducing the incidence of viral respiratory tract infections and bacterial co-infections. S. salivarius K12 has been proposed as a promising agent for prophylactic or probiotic treatments to protect individuals during the outbreak of seasonal or emerging respiratory infection diseases.

S. salivarius K12 strain, commonly known as BLIS K12, is a highly safe, and extensively-studied probiotic that resides in the oral cavity. BLIS K12 has a solid scienctific rationale for helping to prevent streptococcal pharyngitis and/or tonsillitis, ear infections (otitis media) and to help treat halitosis. It is a specific strain of Streptococcus Salivarius, which secretes powerful anti-microbial molecule called Bacteriocin-Like-Inhibitory Substances (BLIS). The ingredient is believed to support healthy bacteria in the mouth for long-term fresh breath and immune support.

It is proposed that the oral administration of the strain K12 to hospitalized COVID-19 patients (not already in ICU) receiving supplementary oxygen (not invasive oxygen theraphy) to exploit the "ventilation" and helping S. salivarius (K12) to move from the mouth (it is an oral colonizer) to the lungs, colonizing them. The idea is that the lung presence of K12 could strategically reduce the lung and immune capability to release pro-inflammatory cytokines, thus preventing excessive lung inflammation, and the need to proceed to ICU and death.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • King Edward Medical University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years (both sexes)
• Hospitalized confirmed (RT-PCR) COVID-19 patients (not already in ICU) admitted for treatment of COVID-19 and not receiving mechanical ventilatory support
• Patients who have signed informed consent

Exclusion Criteria:

• Patients with proven hypersensitivity or allergic reaction to the tested formula
• Patients who decline to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; In this arm patients will receive the standard COVID-19 care as per the hospital guidelines.	Drug: Standard of care; Standard COVID-19 care as per the hospital guidelines
Experimental: BLIS K12; In this arm patients will receive the BLIS K12 as add-on to the standard COVID-19 care	Drug: Standard of care; Standard COVID-19 care as per the hospital guidelines; Dietary supplement: BLIS K12; Daily 2 oral BLIS K12 tablets for up to 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery and live discharge	Number of patients with clinical improvement	From day 1 to day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalisation days	The effect of K12 treatment in reducing the hospitalisation days	From day 1 to day 14
Effect on inflammatory markers	Numbers of patients with improvement in the inflammatory markers	From day 1 to day 14
ICU transfer	Reduction in the rate of ICU transfer	From day 1 to day 14

Collaborators and Investigators

• Sponsor: King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): November 21, 2021
• Study Completion (Actual): November 21, 2021

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 11, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 22, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 625/RC/KEMU/07.09.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No