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

Covid19 Clinical Trial

Official title:

Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847349
• Other study ID #: Pro2021000186
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 31, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Danisco USA Inc., Vault Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the titer of serum anti-SARS-CoV-2 IgG		between baseline and day 42
Secondary	Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody		between baseline and days 21 and 42
Secondary	Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody		between baseline and days 21 and 42
Secondary	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
Secondary	Serum cytokine levels		between baseline and days 21 and 42
Secondary	Adverse events		up to 10 weeks
Secondary	Change in any baseline symptoms from prior SARS-CoV-2 infection		up to 6 weeks
Secondary	New (repeat) SARS-CoV-2 infections		up to 6 weeks

External Links

•   Trial landing page with screening form to confirm eligibility