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

Rutgers, The State University of New Jersey54 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Covid19

Interventions

OL-1, standard doseDIETARY_SUPPLEMENT

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.

OL-1, high doseDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rutgers University

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Change in the titer of serum anti-SARS-CoV-2 IgG

Time frame: 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

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

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

Serum cytokine levels

Time frame: between baseline and days 21 and 42

Adverse events

Time frame: up to 10 weeks

Change in any baseline symptoms from prior SARS-CoV-2 infection

Time frame: up to 6 weeks

New (repeat) SARS-CoV-2 infections

Time frame: up to 6 weeks

Data from ClinicalTrials.gov

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