Anti-phospolipid Antibodies in Lyme Borreliosis

University Medical Centre Ljubljana

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Anti-phospholipid antibodies

Study type: Observational

Funder types: Other

Identifiers

NCT06929546

0120-571/2024-2711-3

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).

Exclusion criteria

Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.

Trial design

240 participants in 3 patient groups

Patients with different well-defined manifestations of Lyme borreliosis

Description:

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).

Treatment:

Diagnostic Test: Anti-phospholipid antibodies

Patients with nonspecific symptoms and positive borrelial antibodies in serum.

Description:

50 patients with nonspecific symptoms and positive borrelial antibodies in serum.

Treatment:

Diagnostic Test: Anti-phospholipid antibodies

Blood donors

Description:

40 healthy blood donors.

Treatment:

Diagnostic Test: Anti-phospholipid antibodies