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Study identifier: NCT06045416 Synced from ClinicalTrials.gov · July 29, 2026
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Borrelia B-cell Diagnostics

Condition: Lyme Disease · Borrelia Infections  ·  Sponsor: University Children's Hospital, Zurich

PhaseN/A
Planned participants502
Who can joinAll sexes, 1 Month to 17 Years
Healthy volunteersYes

About this study

The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives: 1. Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD. There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD. 2. Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets/phenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking. 3. Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and/or genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies/genotypes in different manifestation of LD are lacking. 4. Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD. 5. Biobanking samples for anal…

This description comes directly from the study's public registry record.

Talk to the study team

Patrick M Meyer Sauteur, MD PhD  ·  0041 44 266 78 96  ·  patrick.meyersauteur@kispi.uzh.ch

Christoph Berger, MD  ·  christoph.berger@kispi.uzh.ch

Always discuss trial participation with your own doctor first.

Locations (1)

Chidren's Hospital ZurichZurich, SwitzerlandRecruiting

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Source record: clinicaltrials.gov/study/NCT06045416