Impact of Lp299v on Vascular Function in Patients With PASC
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT05227170
- Run by
- Medical College of Wisconsin
- People needed
- 80
- Starts
- 2022-04-29
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 18 to 89 years
- 30-180 days post-COVID-19 diagnosis
- PASC diagnosed based on symptom report/expert physician judgement
You may not qualify if…
- 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)
Where it is running
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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