Clinical trial NCT06929546: Anti-phospolipid Antibodies in Lyme Borreliosis
Official title: Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patients With Different Manifestations of Lyme Borreliosis
Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
Blood Donors
Keywords: Lyme borreliosis
Erythema migrans
Lyme neuroborreliosis
Lyme arthritis
Acrodermatitis chronica atrophicans
Anti-phospholipid antibodies
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Adult patients diagnosed with well-defined manifestations of Lyme borreliosis (according to European case definition) at the Outpatient Lyme borreliosis clinic.
2. Adult patients with nonspecific symptoms and positive borrelial antibodies in serum referred to Outpatient Lyme borreliosis clinic.
3. Adult healthy blood donors.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment.
timeFrame: Baseline
measure: 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
timeFrame: Up to one year.
Secondary outcomes:
measure: 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).
timeFrame: 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References: