Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT04847349
• Collaborator: Vault Health, Inc. (Other), Danisco USA Inc. (Other)
• Enrollment: 54
• Location: 1
• Arms: 3
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Dietary Supplement: OL-1, standard dose; Dietary Supplement: OL-1, high dose; Dietary Supplement: Placebo	N/A

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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)
• Actual Study Start Date: Apr 13, 2021
• Actual Primary Completion Date: Nov 1, 2021
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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.
Experimental: 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.	Dietary Supplement: 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 Comparator: 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.	Dietary Supplement: Placebo; Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Change in the titer of serum anti-SARS-CoV-2 IgG [between baseline and day 42]

2. Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody [between baseline and days 21 and 42]

3. Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody [between baseline and days 21 and 42]

4. 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]

5. Serum cytokine levels [between baseline and days 21 and 42]

6. Adverse events [up to 10 weeks]

7. Change in any baseline symptoms from prior SARS-CoV-2 infection [up to 6 weeks]

8. New (repeat) SARS-CoV-2 infections [up to 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers University	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• Vault Health, Inc.
• Danisco USA Inc.

Investigators

• Principal Investigator: Daniel B Horton, MD, MSCE, Rutgers University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Trial landing page with screening form to confirm eligibility

Publications

None provided.

• Responsible Party: Daniel B. Horton, MD, MSCE, Assistant Professor of Pediatrics and Epidemiology, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT04847349
• Other Study ID Numbers: Pro2021000186
• First Posted: Apr 19, 2021
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel B. Horton, MD, MSCE, Assistant Professor of Pediatrics and Epidemiology, Rutgers, The State University of New Jersey: Probiotics

Study Results

No Results Posted as of Feb 1, 2022