Covid19
Conditions
Keywords
Probiotics
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.
Interventions
DIETARY_SUPPLEMENTOL-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.
DIETARY_SUPPLEMENTOL-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.
DIETARY_SUPPLEMENTPlacebo
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
Sponsors
Vault Health, Inc.
Danisco USA Inc.
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Change in the titer of serum anti-SARS-CoV-2 IgG | between baseline and day 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 |
| Serum cytokine levels | between baseline and days 21 and 42 |
Countries
United States
Outcome results
None listed