An interventional study of OL-1, standard dose and OL-1, high dose in Covid19, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Basic science
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.
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.
Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: OL-1, standard 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.
Dietary Supplement: OL-1, high dose
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days.
Dietary Supplement: Placebo
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.
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG)
Time frame: between baseline and day 21 (day 1 is the first day of taking the investigational product)
Change in the titer of serum anti-SARS-CoV-2 IgG
Time frame: between baseline and day 42
Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody
Time frame: between baseline and days 21 and 42
Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody
Time frame: 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
Time frame: between baseline and days 21 and 42
Serum cytokine levels
Time frame: between baseline and days 21 and 42
Adverse events
Time frame: up to 10 weeks
Change in any baseline symptoms from prior SARS-CoV-2 infection
Time frame: up to 6 weeks
New (repeat) SARS-CoV-2 infections
Time frame: up to 6 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey