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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Dietary Supplement: OL-1, high dose; Dietary Supplement: Placebo; Dietary Supplement: OL-1, standard dose

• Registration Number: NCT04847349
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2021-04-13
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Primary Completion: 2021-11-01
• Status Verified: 2022-01
• Study Completion: 2022-01-31
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Live microbial (Probiotic) consortium OL-1, high dose	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 for live microbial (probiotic) consortium	Placebo	Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days.
Live microbial (Probiotic) consortium OL-1, standard dose	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 any baseline symptoms from prior SARS-CoV-2 infection	up to 6 weeks
Serum cytokine levels	between baseline and days 21 and 42
Adverse events	up to 10 weeks
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
New (repeat) SARS-CoV-2 infections	up to 6 weeks

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States