Clinical trial Recruiting at 1 site Observational Ages 1 Month to 17

Assessing immune response in children with Lyme disease

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

Run by University Children's Hospital, Zurich · NCT06045416 · Data updated 2026-11-12

This study is testing a new blood test to see how children's immune systems respond to Lyme disease to help doctors diagnose it earlier and better.

Quick facts

Study typeObservational
Ages1 Month to 17 Years
SexAll
Enrollment502 (estimated)
SponsorUniversity Children's Hospital, Zurich
Academic / other
Locations1 site (Zurich)
StatusRecruiting
StartedApril 2, 2024
Main results expectedNovember 1, 2026
Study endsNovember 1, 2028
Registry record updatedApril 28, 2026
Trial IDNCT06045416 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 0-17 years presenting with symptoms indicative of Lyme disease.

Probably not a fit

Patients with primary or secondary immunodeficiency will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the immune response against Borrelia burgdorferi in children diagnosed with Lyme disease. It will develop a new diagnostic tool using the Bb-specific ASC ELISpot assay to improve early diagnosis, addressing the limitations of current testing methods. The study will enroll 502 patients aged 0-17 years who present with symptoms suggestive of Lyme disease, alongside healthy controls. Blood samples will be collected at initial hospital visits and follow-up appointments to analyze immune cell responses.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for early Lyme disease, potentially reducing misdiagnosis and treatment delays.

How similar studies have gone: While there have been studies on Lyme disease diagnostics, the specific approach of using Bb-specific ASC ELISpot is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients presenting at the ED with differential diagnosis of LD according to the treating physician

Exclusion Criteria:

* Patients will be excluded in cases of primary or secondary immunodeficiency

Where it's running

  • Chidren's Hospital Zurich
    Zurich, Switzerland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.