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Sponsor: Medical College of Wisconsin
Conditions: COVID-19
Interventions: Lactobacillus Plantarum 299v Freeze Dried Capsule, Freeze Dried Potato Starch Capsule
Countries: United States
Emerging data show that SARS-CoV-2 infection causes gut microbiome changes strongly associated with Post-Acute Sequelae of SARS-CoV-2 (PASC). The investigators and others have established that an orally ingested probiotic (Lactobacillus plantarum 299v, Lp299v) reduces circulating levels of cell-free mitochondrial DNA (cf-mtDNA), decreases toll-like receptor 9 (TLR9) activation \[and downstream interleukin (IL-6)\], and improves micro- and macrovascular (brachial artery) endothelial dysfunction \[as measured by flow-mediated dilation (FMD%)\] in humans. Recently published data also report impaired brachial FMD% and increased vascular stiffness post-SARS-CoV-2 infection. Based on these data, the investigators hypothesize that supplementation with Lp299v will attenuate SARS-CoV-2 associated endothelial dysfunction by reducing cf-mtDNA, TLR9 activation, and inflammation.
Sex: ALL
Age: 18 Years to 89 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Ages 18 to 89 years * 30-180 days post-COVID-19 diagnosis * PASC diagnosed based on symptom report/expert physician judgement Exclusion Criteria: * Antibiotics within four weeks of enrollment * History of chronic diseases (renal insufficiency, liver dysfunction, cancer requiring systemic treatment within 3 years of enrollment) * History of cognitive impairment/inability to follow study procedures * Short gut syndrome, inflammatory bowel disease, or an ileostomy. * Subjects currently taking Vitamin K antagonists such as coumadin or warfarin * Pregnant at the time of screening * Unstable coronary artery disease (new symptoms or event within 30 days of enrollment) * Daily alcohol use (may interfere with Lp299v's action)
- Milwaukee, Wisconsin, United States