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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: OL-1, standard dose
* Dietary Supplement: OL-1, high dose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live microbial (Probiotic) consortium OL-1, standard dose<br>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<br>* 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.<br>|
| Experimental: Live microbial (Probiotic) consortium OL-1, high dose<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo for live microbial (probiotic) consortium<br>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<br>* Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics