Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04847349
- Status
- Completed
- Sponsor
- Rutgers, The State University of New Jersey
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.