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NCT06929546
Anti-phospolipid Antibodies in Lyme Borreliosis
trial testing Anti-phospholipid antibodies in Patients With Different Manifestations of Lyme Borreliosis in 240 participants. Not yet recruiting.
15 May 2026
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 15 May 2025 |
| Primary completion | 15 May 2026 |
| Estimated completion | 15 July 2026 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- Anti-phospholipid antibodies
Conditions studied
- Patients With Different Manifestations of Lyme Borreliosis — all drugs for Patients With Different Manifestations of Lyme Borreliosis →
- Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum — all drugs for Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum →
- Blood Donors — all drugs for Blood Donors →
Sponsor
University Medical Centre Ljubljana
Who can join
18 and older, any sex, with Patients With Different Manifestations of Lyme Borreliosis or Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. Several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti-phospholipid antibodies that are believed to arose early in infection. Here we aimed to investigate the levels of anti-phospholipid antibodies in patients with Lyme borreliosis. Methods Participants included in the study: * 150 patients with well-defined Lyme borreliosis, of which 30 presented with solitary erythema migrans (EM), 30 with multiple EM (MEM), 30 with Lyme neuroborreliosis (LNB), 30 with Lyme arthritis (LA), 30 with acrodermatitis chronica atrophicans (ACA); * 50 patients with nonspecific symptoms and positive borrelial antibodies in serum; and * 40 healthy blood donors (control group; samples from healthy blood donors were used to determine the threshold for the assays). Specimens: * 4 serum samples from each individual patient with well-defined Lyme borreliosis (1 before antibiotic treatment, 3 during follow-up up to 1 year); * 2 serum samples from patients with nonspecific symptoms and positive borrelial antibodies (1 before antibiotic treatment and one 3 months later); * healthy blood donors: 1 serum specimen. Anti-phospolipid antibodies: Levels of IgG and IgM isotypes of 4 anti-phospholipid antibodies including anti-cardiolipin (aCL), anti-phosphatidylserine (aPS), anti-phosphatidic acid (aPA) and anti-phosphatidylcholine (aPC) will be analyzed with in-house ELISAs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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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 NCT06929546 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
- Last refreshed: 16 April 2025
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