Impact of Lp299v on Vascular Function in Patients With PASC

NCT05227170 | Active Not Recruiting

• 1 other identifier: PRO42931
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

endothelial function; PASC; COVID-19; inflammation; microbiome

Outcome Measures

Primary Outcomes (1)

• Brachial Artery Flow Mediated Dilation (FMD%)

  This is a measurement of endothelial function in the brachial artery

  8 weeks

Secondary Outcomes (10)

• Nitroglycerin-Mediated Vasodilation of the brachial artery (NMD)

  8 weeks

• Hyperemic Flow Velocity

  8 weeks

• Carotid-Femoral Pulse Wave Velocity (cfPWV)

  8 weeks

• Percentage of Laser Doppler Signal

  8 weeks

• interleukin-6

  8 weeks

Study Arms (2)

Lp299v

EXPERIMENTAL

Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 8 weeks.

Other: Lactobacillus Plantarum 299v Freeze Dried Capsule

Heat-killed placebo control

PLACEBO COMPARATOR

Subjects will consume potato starch (2 capsules) once daily for 8 weeks.

Other: Freeze Dried Potato Starch Capsule

Interventions

Lactobacillus Plantarum 299v Freeze Dried Capsule OTHER

The intervention is a probiotic lactobacillus that is contained in food products in the US

Lp299v

Freeze Dried Potato Starch Capsule OTHER

The intervention is potato starch that is freeze dried designed to mimic the lp299v capsule.

Heat-killed placebo control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 89 years
• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

COVID-19; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael E Widlansky, MD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: April 29, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 1 year of completion of all studies procedures.

Locations

US (1)