Anti-phospolipid Antibodies in Lyme Borreliosis

NCT06929546 | Not Yet Recruiting

• 1 other identifier: 0120-571/2024-2711-3
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum; Blood Donors; Patients With Different Manifestations of Lyme Borreliosis

Keywords

Lyme borreliosis; Erythema migrans; Lyme neuroborreliosis; Lyme arthritis; Acrodermatitis chronica atrophicans; Anti-phospholipid antibodies

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  3 months

Study Arms (3)

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).

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.

Diagnostic Test: Anti-phospholipid antibodies

Blood donors

40 healthy blood donors.

Diagnostic Test: Anti-phospholipid antibodies

Interventions

Anti-phospholipid antibodies DIAGNOSTIC_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.

Blood donors; Patients with different well-defined manifestations of Lyme borreliosis; Patients with nonspecific symptoms and positive borrelial antibodies in serum.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).

You may not qualify if:

• Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1525, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Lyme Disease; Glossitis, Benign Migratory; Lyme Neuroborreliosis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Petra Bogovič, MD, PhD

CONTACT

+386 1 522 2110; petra.bogovic@kclj.si

Franc Strle, MD, PhD

CONTACT

+386 1 522 4219; franc.strle@kclj.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 16, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)