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

Rutgers The State University of New Jersey

Status: Completed

Conditions: Covid19

Treatments: Dietary Supplement: OL-1, high dose; Dietary Supplement: OL-1, standard dose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04847349

Pro2021000186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

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

Experimental group

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.

Treatment:

Dietary Supplement: OL-1, standard dose

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

Experimental group

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.

Treatment:

Dietary Supplement: OL-1, high dose

Placebo for live microbial (probiotic) consortium

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo