Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2021
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 1, 2022
January 1, 2022
7 months
April 13, 2021
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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 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
Serum cytokine levels
between baseline and days 21 and 42
- +3 more secondary outcomes
Study Arms (3)
Live microbial (Probiotic) consortium OL-1, standard dose
EXPERIMENTALCombination 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.
Live microbial (Probiotic) consortium OL-1, high dose
EXPERIMENTALCombination 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 COMPARATORCapsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days.
Interventions
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.
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.
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Vault Health, Inc.collaborator
- Danisco USA Inc.collaborator
Study Sites (1)
Rutgers University
New Brunswick, New Jersey, 08901, United States
Related Publications (1)
Horton DB, Ukey R, Madhvi A, Andrews T, Parmar V, Reilly N, Makela SM, Peterson J, Hustad L, Wong G, Barrett ES, Bruiners N, Carson JL, Getz K, Greenberg P, Iizuka A, Roy J, Pastuszak AW, Lehtinen MJ, Blaser MJ, Panettieri RA Jr, Gennaro ML. Live microbials to boost Anti-SARS-CoV-2 immunity clinical trial (Live BASIC trial): a triple-blind randomized controlled trial. Infection. 2025 Nov 26. doi: 10.1007/s15010-025-02697-4. Online ahead of print.
PMID: 41299123DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel B Horton, MD, MSCE
Rutgers University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics and Epidemiology
Study Record Dates
First Submitted
April 13, 2021
First Posted
April 19, 2021
Study Start
April 13, 2021
Primary Completion
November 1, 2021
Study Completion
January 31, 2022
Last Updated
February 1, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be shared after enrollment and data analysis are completed.
Saliva, nasal rinse, blood samples, and stool samples collected will be used for the purposes of this research. After information that could identify consenting participants has been removed, de-identified information and left over biospecimens collected for this research may be used by or distributed to the study funder (Danisco USA Inc.) or to investigators for other research without obtaining additional informed consent. Personal identifying details, such as name and date of birth, will not be shared without participants' additional permission.