University Medical Center Ljubljana
Ljubljana, 1525, Slovenia
NCT Number: NCT06929546
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Ljubljana, 1525, Slovenia
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.
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.
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Franc Strle, MD, PhD
CONTACT
Petra Bogovič, MD, PhD
CONTACT
University Medical Centre Ljubljana
Other
Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis
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