Blood Donors, Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
Conditions
Keywords
Lyme borreliosis, Erythema migrans, Lyme neuroborreliosis, Lyme arthritis, Acrodermatitis chronica atrophicans, Anti-phospholipid antibodies
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.
Interventions
DIAGNOSTIC_TESTAnti-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.
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment. | 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. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
Countries
Slovenia
Contacts
Primary ContactPetra Bogovič, MD, PhD
Backup ContactFranc Strle, MD, PhD
Outcome results
None listed