Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Diarrhea
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open label trial of Bismuth subsalicylate (10 patients) followed by placebo controlled study (25 patients) for mild to moderate COVID-19+ patients.Masking: Single (Outcomes Assessor)Masking Description: Member of research team not involved in patient care.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Readily available over-the-counter (OTC) medication for symptomatic relief and appropriate oral hydration can be health saving measures of great convenience for those affected by enteric bacterial and viral infections. BSS is a non-proprietary monograph product that is available in the USA and abroa...
Readily available over-the-counter (OTC) medication for symptomatic relief and appropriate oral hydration can be health saving measures of great convenience for those affected by enteric bacterial and viral infections. BSS is a non-proprietary monograph product that is available in the USA and abroad, over-the-counter (OTC). Of all OTC medications for traveller's diarrhea (TD), bismuth subsalicylate (BSS) has the greatest antimicrobial activity against pathogenic bacteria .BSS has also exhibited significant inhibition on viral invasion of host cells and viral efficacy. Both BSS and bismuth oxychloride (BiOCl, which is formed in the stomach after ingestion of BSS) at low concentration (0.004-0.13mg/mL) significantly reduced NoV RNA levels, suggesting an in vivo antiviral mechanism. BSS has also been shown to have antiviral activity since it inhibited replication of 4 strains of rotavirus in tissue culture cells and caused a dose-dependent reduction in the growth of several enteric viruses. Historically, BSS has been indicated and effectively used for the treatment of TD or enteric infection, mainly when vomiting occurs. Although the safety and efficacy of BSS is well known, some of the research done with BSS resides within the industry and have not been published. We have recently completed an extensive meta-analysis using unpublished clinical studies regarding BSS safety and efficacy. Meta-analyses of randomized controlled clinical trials were performed with studies specifically designed to capture prevention of manifestation and relief of diarrhea.
Tracking Information
- NCT #
- NCT04811339
- Collaborators
- Procter and Gamble
- Investigators
- Not Provided