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

NCT04847349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-02-01

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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.

Sponsors & Collaborators

  • Vault Health, Inc.

    collaborator UNKNOWN

  • Danisco USA Inc.

    collaborator UNKNOWN

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Daniel B Horton, MD, MSCE · Rutgers University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2021-11-01
Completion
2022-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847349 on ClinicalTrials.gov