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NCT Number: NCT06929546

Anti-phospolipid Antibodies in Lyme Borreliosis

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-phospholipid antibodies

Diagnostic Test

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.

Primary outcomes

  1. Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment.

    Time frame: Baseline

    In all patients with well-defined Lyme borreliosis (EM, multiple EM, LNB, LA, ACA) levels of anti-phospholipid antibodies (AUG/AUM) will be determined before antibiotic treatment.

  2. Levels of anti-phospholipid antibodies in patients with well-defined Lyme borreliosis (EM, multiple EM, LNB, LA, ACA) during the 1-year follow-up after antibiotic treatment.herapy in patients with well-defined Lyme borreliosis

    Time frame: Up to one year.

    Antiphospholipid antibody levels (AUG/AUM) will be determined in 3 serum samples from each individual patient with well-defined Lyme borreliosis during follow-up up to 1 year.

Secondary outcomes

  1. Levels of anti-phospholipid antibodies in patients with nonspecific symptoms and positive borrelial antibodies in serum. Levels of anti-phospholipid antibodies in control group (healthy blood donors).

    Time frame: 3 months

    Determination of anti-phospholipid antibodies (AUG/AUM) in patients with nonspecific symptoms and positive borrelial antibodies will be determined before antibiotic treatment and 3 months later.

    Determination of anti-phospholipid antibodies in healthy blood donors (one specimen per donor).

Study contacts

Contact information is provided by the study sponsor or research team.

Franc Strle, MD, PhD

CONTACT

[email protected]

+386 1 522 4219

Petra Bogovič, MD, PhD

CONTACT

[email protected]

+386 1 522 2110

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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