Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)

What this Trial Is About

Researchers are conducting an observational study called the BRILLIANT study to better understand Lyme disease (LD) in children aged 0 to 17 years. This study aims to develop a new diagnostic test for early LD by measuring Borrelia burgdorferi-specific antibody-secreting cells (ASCs) and to analyze the immune response in children with LD. The study also seeks to identify different strains of the bacteria causing LD and gather clinical data on symptoms, disease severity, treatment, and outcomes. The study involves two groups: children suspected of having LD presenting in the emergency department, and previously healthy children undergoing routine blood tests as controls. Participants will provide venous blood samples at their first hospital visit and during follow-up visits at 28 days, 3 months, and 6 months. Additional samples of cerebrospinal fluid or joint fluid may be collected if medically needed. Researchers will use various laboratory techniques such as ELISpot, flow cytometry, and genome sequencing to study the immune response and bacterial types. Participants will have clinical and laboratory data collected at multiple visits, including symptoms, routine tests, and treatment information. The study will monitor immune cells, antibody levels, and bacterial presence over time. The primary outcome is the number of Borrelia-specific ASCs in blood, measured between October 2023 and October 2026. Secondary outcomes include immune cell measurements, antibody levels, T cell counts, cytokine levels, and bacterial typing through October 2028. The total participation lasts up to six months with scheduled follow-ups for thorough monitoring.

Borrelia B-cell Diagnostics