Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
NCT ID: NCT04847349
Last Updated: 2022-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2021-04-13
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
OL-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.
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.
OL-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.
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.
Placebo
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
Interventions
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OL-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.
OL-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.
Placebo
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Vault Health, Inc.
UNKNOWN
Danisco USA Inc.
UNKNOWN
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Daniel B. Horton, MD, MSCE
Assistant Professor of Pediatrics and Epidemiology
Principal Investigators
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Daniel B Horton, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Rutgers University
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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Pro2021000186
Identifier Type: -
Identifier Source: org_study_id
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