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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043376
• Other study ID #: 625/RC/KEMU/07.09.2021
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: November 21, 2021

Study information

• Verified date: January 2022
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 21, 2021
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Pakistan	King Edward Medical University Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery and live discharge	Number of patients with clinical improvement	From day 1 to day 14
Secondary	Hospitalisation days	The effect of K12 treatment in reducing the hospitalisation days	From day 1 to day 14
Secondary	Effect on inflammatory markers	Numbers of patients with improvement in the inflammatory markers	From day 1 to day 14
Secondary	ICU transfer	Reduction in the rate of ICU transfer	From day 1 to day 14