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NCT05227170
Impact of Lp299v on Vascular Function in Patients With PASC
NA trial testing Lactobacillus Plantarum 299v Freeze Dried Capsule in COVID-19 in 80 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2025
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 80 |
| Start date | 29 April 2022 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lactobacillus Plantarum 299v Freeze Dried Capsule
- Freeze Dried Potato Starch Capsule
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Medical College of Wisconsin
Who can join
Adults 18 to 89, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical trials on the pharmacological treatment of long COVID: A systematic review.
Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289 -
Clinical Implications of COVID-19-Related Endothelial Dysfunction.
Aljadah M, Khan N, Beyer AM, Chen Y, et al · · 2024 · cited 20× · PMID 39055276 · DOI 10.1016/j.jacadv.2024.101070 -
COVID-19 influenced gut dysbiosis, post-acute sequelae, immune regulation, and therapeutic regimens.
Raj ST, Bruce AW, Anbalagan M, Srinivasan H, et al · · 2024 · cited 19× · PMID 38863829 · DOI 10.3389/fcimb.2024.1384939 -
Long COVID: Long-Term Impact of SARS-CoV2.
Makhluf H, Madany H, Kim K. · · 2024 · cited 19× · PMID 38611624 · DOI 10.3390/diagnostics14070711 -
COVID-19 and Gut Injury.
Shen S, Gong M, Wang G, Dua K, et al · · 2022 · cited 12× · PMID 36297092 · DOI 10.3390/nu14204409 -
Association of SARS-CoV-2 and Polypharmacy with Gut-Lung Axis: From Pathogenesis to Treatment.
Malik JA, Ahmed S, Yaseen Z, Alanazi M, et al · · 2022 · cited 11× · PMID 36164411 · DOI 10.1021/acsomega.2c02524
Verify or expand the search:
- PubMed search for NCT05227170
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lactobacillus Plantarum 299v Freeze Dried Capsule
Trials testing the same drug.
- NCT05752760 — Pilot Study Lp299v Supplementation in Chronic Heart Failure · NA · recruiting
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Medical College of Wisconsin trials
Trials by the same sponsor.
- NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
- NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
- NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
- NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
- NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05227170 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
- Last refreshed: 27 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05227170.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing