NCT04847349

Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial

Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.

Detailed description

This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed SARS-CoV-2 infection. Data collected will include demographics, comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.

Conditions

• Covid19

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	OL-1, standard dose	The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
DIETARY_SUPPLEMENT	OL-1, high dose	The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
DIETARY_SUPPLEMENT	Placebo	Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.

Timeline

• Start date: 2021-04-13
• Primary completion: 2021-11-01
• Completion: 2022-01-31
• First posted: 2021-04-19
• Last updated: 2022-02-01

Locations

1 site across 1 country: United States