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| Name | Class |
|---|---|
| Vault Health, Inc. | UNKNOWN |
| Danisco USA Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live microbial (Probiotic) consortium OL-1, standard dose | Experimental | 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. |
|
| Live microbial (Probiotic) consortium OL-1, high dose | Experimental | 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 Comparator | Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OL-1, standard dose | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B Horton, MD, MSCE | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41299123 | Derived | 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. 2026 Feb;54(1):473-485. doi: 10.1007/s15010-025-02697-4. Epub 2025 Nov 26. |
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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.
Data will be shared after enrollment and data analysis are completed.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OL-1, high dose | Dietary Supplement | 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 | Dietary Supplement | Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics. |
|
| 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 |
| Adverse events | up to 10 weeks |
| Change in any baseline symptoms from prior SARS-CoV-2 infection | up to 6 weeks |
| New (repeat) SARS-CoV-2 infections | up to 6 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |