T-cell response in Lyme disease (TRIL-study)
Recruiting
- Conditions
- Lyme disease/ Lyme borreliosis10004018
- Registration Number
- NL-OMON50284
- Lead Sponsor
- Diakonessenhuis Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
- 20 persons with positive Lyme serology who have no symptoms of Borrelia
infection
- 20 persons without Lyme symptoms and negative Lyme serology
- 50 patients treated for Lyme disease such as acute Lyme neuroborreliosis
- 125 patients with active Lyme disease such as acute Lyme neuroborreliosis
- 10-20 patients/disease, consisting of patients with active disease known to
cross-react with Borrelia such as syphilis, leptospirosis, Epstein-Barr virus
(EBV), cytomegalovirus (CMV), Helicobacter pylori, Mycoplasma pneumonia,
rheumatoid arthritis (RA) or the presence of antinuclear antibodies (ANA).
- informed consent
Exclusion Criteria
* immunosuppressive medication
* < 18 years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Results of the Borrelia ELISpot assay and conventional two-tier serology for<br /><br>patients with Lyme disease and healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method