Status:
COMPLETED
Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Vault Health, Inc.
Danisco USA Inc.
Conditions:
Covid19
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
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 market...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04847349
Start Date
April 13 2021
End Date
January 31 2022
Last Update
February 1 2022
Active Locations (1)
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1
Rutgers University
New Brunswick, New Jersey, United States, 08901