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Completed

NCT Number: NCT04847349

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in the titer of serum anti-SARS-CoV-2 IgG

    Time frame: between baseline and day 42

  2. Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody

    Time frame: between baseline and days 21 and 42

  3. 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

  4. 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

  5. Serum cytokine levels

    Time frame: between baseline and days 21 and 42

  6. Adverse events

    Time frame: up to 10 weeks

  7. Change in any baseline symptoms from prior SARS-CoV-2 infection

    Time frame: up to 6 weeks

  8. New (repeat) SARS-CoV-2 infections

    Time frame: up to 6 weeks

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Danisco USA Inc.
  • Vault Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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