Measuring anti-phospholipid antibodies in adults with Lyme borreliosis
Measures anti-phospholipid antibodies in blood of adults with Lyme borreliosis and comparison groups.
Key facts
- Who runs it
- University Medical Centre Ljubljana
- Where
- Ljubljana, SloveniaSee the site
- Trial code
- Registry title
- Anti-phospolipid Antibodies in Lyme Borreliosis
- Status
- Not yet recruiting
- People taking part
- 240 people, planned
- Started
- 15 May 2025
- Planned end
- 15 Jul 2026
- Type of study
- Observational, 3 groups
- Treatments tested
- Anti-phospholipid antibodies
- Record updated
- 16 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Lyme borreliosis, a disease spread by tick bites. It also includes people with nonspecific symptoms and Borrelia antibodies in the blood, and healthy blood donors. Researchers will measure anti-phospholipid antibodies in blood samples.
- Age
- 18 Years and older
- Sex
- All sexes
- Disease stage
- Lyme borreliosis that meets the European clinical case definition. Forms include solitary or multiple erythema migrans (skin rash), Lyme neuroborreliosis (nerves), Lyme arthritis (joints) and acrodermatitis chronica atrophicans (long-term skin form). There is also a group with nonspecific symptoms.
- Earlier treatment
- The first blood sample is taken before antibiotic treatment.
- Biomarker or test result
- For the nonspecific symptoms group: positive Borrelia antibodies in the blood serum.
Main reasons for not taking part
- Autoimmune diseases
- Acute heart attack (myocardial infarction)
- Acute deep vein thrombosis (blood clot in a deep vein)
- Pregnancy
- Syphilis
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.)
Who cannot take part
- Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis
Where in Slovenia
- University Medical Center LjubljanaLjubljana, SloveniaContact: UMC Ljubljana, Department of Infectious DiseasesNot yet recruiting
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Patients with different well-defined manifestations of Lyme borreliosis
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: Anti-phospholipid antibodies
- Patients with nonspecific symptoms and positive borrelial antibodies in serum.
50 patients with nonspecific symptoms and positive borrelial antibodies in serum.
Treatment: Anti-phospholipid antibodies
- Blood donors
40 healthy blood donors.
Treatment: Anti-phospholipid antibodies
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis
- Plain-language title
- Measuring anti-phospholipid antibodies in adults with Lyme borreliosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 16 April 2025