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

Sponsor

King Edward Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05043376

Collaborator

(none)

Enrollment

Location

Arms

2.4

Actual Duration (Months)

21.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Standard of care Dietary Supplement: BLIS K12	N/A

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 10, 2021

Actual Primary Completion Date :

Nov 21, 2021

Actual Study Completion Date :

Nov 21, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recovery and live discharge [From day 1 to day 14]
Number of patients with clinical improvement

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Edward Medical University Teaching Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

King Edward Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

somia iqtadar, Associate Professor of Medicine, King Edward Medical University

ClinicalTrials.gov Identifier:

NCT05043376

Other Study ID Numbers:

625/RC/KEMU/07.09.2021

First Posted:

Sep 14, 2021

Last Update Posted:

Feb 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 4, 2022