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)

Sponsors

Lead Sponsor: Rutgers, The State University of New Jersey

Collaborator: Vault Health, Inc.
Danisco

Source Rutgers, The State University of New Jersey
Brief 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.

Overall Status Recruiting
Start Date 2021-04-13
Completion Date 2022-10-01
Primary Completion Date 2021-10-13
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG) between baseline and day 21 (day 1 is the first day of taking the investigational product)
Secondary Outcome
Measure Time Frame
Change in the titer of serum anti-SARS-CoV-2 IgG between baseline and day 42
Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody between baseline and days 21 and 42
Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody 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 between baseline and days 21 and 42
Serum cytokine levels between baseline and days 21 and 42
Adverse events up to 10 weeks
Change in any baseline symptoms from prior SARS-CoV-2 infection up to 6 weeks
New (repeat) SARS-CoV-2 infections up to 6 weeks
Enrollment 45
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: OL-1, standard dose

Description: 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.

Arm Group Label: Live microbial (Probiotic) consortium OL-1, standard dose

Intervention Type: Dietary Supplement

Intervention Name: OL-1, high dose

Description: 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.

Arm Group Label: Live microbial (Probiotic) consortium OL-1, high dose

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.

Arm Group Label: Placebo for live microbial (probiotic) consortium

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Daniel B Horton, MD, MSCE Principal Investigator Rutgers University
Overall Contact

Last Name: Vault Health, Inc.

Phone: 929-390-4709

Email: [email protected]

Location
Facility: Status: Contact: Rutgers University Vault Health, Inc. 929-390-4709 [email protected]
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rutgers, The State University of New Jersey

Investigator Full Name: Daniel B. Horton, MD, MSCE

Investigator Title: Assistant Professor of Pediatrics and Epidemiology

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Live microbial (Probiotic) consortium OL-1, standard dose

Type: Experimental

Description: 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.

Label: Live microbial (Probiotic) consortium OL-1, high dose

Type: Experimental

Description: 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.

Label: Placebo for live microbial (probiotic) consortium

Type: Placebo Comparator

Description: Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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