T-cell response in Lyme disease (TRIL-study)

T-cell response in Lyme disease (TRIL-study) - TRIL-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50284

Enrollment

500

Registered

2011-08-16

Start date

2012-03-15

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme disease/ Lyme borreliosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * immunosuppressive medication *

Design outcomes

Primary

Measure	Time frame
Results of the Borrelia ELISpot assay and conventional two-tier serology for patients with Lyme disease and healthy volunteers.	—

Secondary

Measure	Time frame
1) Results of the Lyme-specific questionnaire and the health-related questionnaire (RAND-36) 2) Results of the specificity tests of: -) the Borrelia ELISpot assay for 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) -) the antibody tests on leptospirosis, Treponema pallidum and Helicobacter pylori for participants with Borrelia specific T cells in their blood and the controls (age and sex matched). 3) Results of the antiganglioside antibody test. 4) Results of the retrospective study in search for possible predisposing factors which can be helpful for clinicians in the decision-making of performing a lumbar puncture in case Lyme neuroborreliosis is suspected. 5) Results of the search for other factors (cytokines and/or immune cells and/or genetic polymorphisms) which might play a rol in the development of Lyme disease and the possible development of persisting complaints, which could be used for optimizing the ELISpot. 6) Identification of new immunological or genetic markers involved in the development of Lyme borreliosis and/or persisting complaints, in order to improve the diagnostics and therapeutic interventions for Lyme borreliosis, and the evaluation of these new tools. 7) Results of the evaluation of tests other than the ELISpot, which detect a response to the pathogen.	—

Measure

Time frame

1) Results of the Lyme-specific questionnaire and the health-related questionnaire (RAND-36) 2) Results of the specificity tests of: -) the Borrelia ELISpot assay for 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) -) the antibody tests on leptospirosis, Treponema pallidum and Helicobacter pylori for participants with Borrelia specific T cells in their blood and the controls (age and sex matched). 3) Results of the antiganglioside antibody test. 4) Results of the retrospective study in search for possible predisposing factors which can be helpful for clinicians in the decision-making of performing a lumbar puncture in case Lyme neuroborreliosis is suspected. 5) Results of the search for other factors (cytokines and/or immune cells and/or genetic polymorphisms) which might play a rol in the development of Lyme disease and the possible development of persisting complaints, which could be used for optimizing the ELISpot. 6) Identification of new immunological or genetic markers involved in the development of Lyme borreliosis and/or persisting complaints, in order to improve the diagnostics and therapeutic interventions for Lyme borreliosis, and the evaluation of these new tools. 7) Results of the evaluation of tests other than the ELISpot, which detect a response to the pathogen.

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Countries

Netherlands

Outcome results