NCT06929546

Anti-phospolipid Antibodies in Lyme Borreliosis

Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Patients With Different Manifestations of Lyme Borreliosis
• Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
• Blood Donors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Anti-phospholipid antibodies	Serum samples will be obtained for determination 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) with in-house ELISAs.

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-05-15
• Completion: 2026-07-15
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: Slovenia