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

January 31, 2022 updated by: Daniel B. Horton, MD, MSCE, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history
  • SARS-CoV-2 infection >4 months prior confirmed by a positive polymerase chain reaction (PCR) or antigen test
  • Body mass index (BMI) of 18.5-39.9 kg/m2
  • Agreement to comply with the protocol and study restrictions
  • Access to internet in addition to willingness and ability to use web-based questionnaires
  • Available for all study visits
  • English-speaking

Exclusion Criteria:

  • Recent infection with coronavirus disease-2019 (COVID-19) (newly positive PCR or antigen test within prior 4 months)
  • Prior receipt of antibody therapies (convalescent or monoclonal) towards COVID-19
  • Prior receipt of vaccines against COVID-19
  • Prior or current participation in a clinical trial of vaccines against COVID-19
  • Scheduled to receive a vaccine against COVID-19 in the following month
  • Regular use of any live microbial (probiotic) supplements
  • Any acute or chronic respiratory tract disease besides mild to moderate asthma
  • Any diagnosed immunodeficiency
  • Current use of immunosuppressive drugs
  • Any diagnosis of chronic gut disease, such as inflammatory bowel disease or irritable bowel syndrome
  • Pregnancy or breastfeeding
  • Recent use of antibiotics
  • Current addiction to alcohol, drugs, or medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Live microbial (Probiotic) consortium OL-1, standard dose
Combination of a standard dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol.
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.
Experimental: Live microbial (Probiotic) consortium OL-1, high dose
Combination of a high dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol.
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.
Placebo Comparator: Placebo for live microbial (probiotic) consortium
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days.
Dietary supplement: Placebo
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG)
Time Frame: between baseline and day 21 (day 1 is the first day of taking the investigational product)
between baseline and day 21 (day 1 is the first day of taking the investigational product)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the titer of serum anti-SARS-CoV-2 IgG
Time Frame: between baseline and day 42
between baseline and day 42
Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody
Time Frame: between baseline and days 21 and 42
between baseline and days 21 and 42
Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody
Time Frame: between baseline and days 21 and 42
between baseline and days 21 and 42
In-vitro changes in cytokine release in response to stimulation of peripheral blood mononuclear cells with SARS-CoV-2 peptides
Time Frame: between baseline and days 21 and 42
between baseline and days 21 and 42
Serum cytokine levels
Time Frame: between baseline and days 21 and 42
between baseline and days 21 and 42
Adverse events
Time Frame: up to 10 weeks
up to 10 weeks
Change in any baseline symptoms from prior SARS-CoV-2 infection
Time Frame: up to 6 weeks
up to 6 weeks
New (repeat) SARS-CoV-2 infections
Time Frame: up to 6 weeks
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Vault Health, Inc.
Danisco USA Inc.

Investigators

  • Principal Investigator: Daniel B Horton, MD, MSCE, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro2021000186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Saliva, nasal rinse, blood samples, and stool samples collected will be used for the purposes of this research.

After information that could identify consenting participants has been removed, de-identified information and left over biospecimens collected for this research may be used by or distributed to the study funder (Danisco USA Inc.) or to investigators for other research without obtaining additional informed consent. Personal identifying details, such as name and date of birth, will not be shared without participants' additional permission.

IPD Sharing Time Frame

Data will be shared after enrollment and data analysis are completed.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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