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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05043376
Enrollment
50
Registered
2021-09-14
Start date
2021-09-10
Completion date
2021-11-21
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

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.

Interventions

DRUGStandard of care

Standard COVID-19 care as per the hospital guidelines

DIETARY_SUPPLEMENTBLIS K12

Daily 2 oral BLIS K12 tablets for up to 14 days.

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery and live dischargeFrom day 1 to day 14Number of patients with clinical improvement

Secondary

MeasureTime frameDescription
Hospitalisation daysFrom day 1 to day 14The effect of K12 treatment in reducing the hospitalisation days
Effect on inflammatory markersFrom day 1 to day 14Numbers of patients with improvement in the inflammatory markers
ICU transferFrom day 1 to day 14Reduction in the rate of ICU transfer

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026