Study Objectives and Background

This study aims to determine whether bacteria persist after antibiotic treatment of Lyme disease (Borrelia burgdorferi) and to elucidate the relationship between persistence and clinical symptoms. Although some patients continue to experience fatigue, arthralgia, and other symptoms after therapy, objective diagnostic criteria are lacking. Consequently, the findings could inform future diagnostic guidelines and therapeutic strategies.

Population and Study Design

The study enrolls participants aged ≥13 years with chronic Lyme disease and ≥18 years for all other groups, including chronic Lyme arthritis, seropositive controls, recovered controls, multiple sclerosis patients, and healthy volunteers. Core procedures comprise leukocyte collection, lumbar puncture, brain MRI, and neuropsychological testing, enabling multidimensional data acquisition. Participants with a positive initial screen are followed at 3–6‑month intervals, and those with confirmed infection receive ceftriaxone therapy.

Diagnostic and Therapeutic Strategy

The study detects Borrelia DNA and antigens in blood, urine, and cerebrospinal fluid, and performs immune‑gene analyses such as HLA typing. This multiplex biomarker approach may offer greater sensitivity and specificity than the antibody assays currently employed for Lyme disease diagnosis. Identical assessments are repeated at 1 week, 3 months, 6 months, and 12 months post‑treatment to systematically evaluate therapeutic efficacy and reinfection.

Market and Industry Impact

Establishing clear diagnostic criteria for post‑treatment Lyme disease syndrome is expected to drive rapid growth in the market for diagnostic kits and biomarker‑based tests. Moreover, the clinical evidence generated will support the development of antibiotics or immunomodulators targeting persistent infection, thereby expanding pharmaceutical and biotech pipelines. As a government‑sponsored initiative, early data will be publicly available, facilitating swift dissemination across academia and industry.