Patients With Different Manifestations of Lyme BorreliosisNCT06929546
Anti-phospolipid Antibodies in Lyme Borreliosis
An observational study of Patients With Different Manifestations of Lyme Borreliosis and Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, Blood Donors
- What is being tested?
- Anti-phospholipid antibodies
- How many people
- 240 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 May 2025to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).
Who cannot join
- Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Medical Center Ljubljana
Ljubljana, 1525
UMC Ljubljana, Department of Infectious Diseases, +386 1 522 2110, katarina.ogrinc@kclj.si
About this study
Official title: Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of 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
Read more
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.
- Conditions
- Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, Blood Donors
- Being tested
- Anti-phospholipid antibodies
- Keywords
- Lyme borreliosis, Erythema migrans, Lyme neuroborreliosis, Lyme arthritis, Acrodermatitis chronica atrophicans, Anti-phospholipid antibodies
- Medical subject headings
- Lyme Disease, Glossitis, Benign Migratory, Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-phospholipid antibodiesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Anti-phospholipid antibodies | |
| Patients with nonspecific symptoms and positive borrelial antibodies in serum. | 50 patients with nonspecific symptoms and positive borrelial antibodies in serum. Receives: Diagnostic Test: Anti-phospholipid antibodies | |
| Blood donors | 40 healthy blood donors. Receives: Diagnostic Test: Anti-phospholipid antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment.
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.
Measured: Baseline
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
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.
Measured: Up to one 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).
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Different Manifestations of Lyme BorreliosisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Bogovič, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929546
- Sponsor's protocol ID
- 0120-571/2024-2711-3
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-phospholipid Antibodies in Adult Patients With Different Clinical Manifestations of Lyme Borreliosis
- ClinicalTrials.gov ID
- NCT06929546
- Acronym / sponsor ID
- 0120-571/2024-2711-3
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with different well-defined manifestations of Lyme borreliosis | – | Diagnostic Test: Anti-phospholipid antibodies150 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). |
| Patients with nonspecific symptoms and positive borrelial antibodies in serum. | – | Diagnostic Test: Anti-phospholipid antibodies50 patients with nonspecific symptoms and positive borrelial antibodies in serum. |
| Blood donors | – | Diagnostic Test: Anti-phospholipid antibodies40 healthy blood donors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).
Key exclusion criteria (1 listed)
- Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-phospholipid antibodiesSerum 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. | Diagnostic test | Blood donors, Patients with different well-defined manifestations of Lyme borreliosis, Patients with nonspecific symptoms and positive borrelial antibodies in serum. |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Different Manifestations of Lyme Borreliosis and Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Bogovič, MD, PhD (+386 1 522 2110, petra.bogovic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-phospholipid antibody levels in well-defined clinical manifestations of Lyme disease before antibiotic treatment. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.