Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ? (DOBI)
Lyme borreliosis (LB) is an infectious disease that may be followed by a post-infectious syndrome known as PTLDS: Post-Treatment Lyme Disease Syndrome.
Its pathophysiological mechanism is currently not fully understood, but several hypotheses have been proposed, including the induction of autoimmune phenomena following infection with Borrelia burgdorferi, either due to the bacterium itself or as a consequence of prolonged antibiotic therapy.
The frequency of occurrence of an autoimmune disease (AID) following Lyme borreliosis is currently unknown. Describing its incidence is a necessary first step.
The goal of this observational study is to describe the incidence of autoimmune disease occurring within six months after treated Lyme borreliosis.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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-
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Nancy, Frankrike
- CHRU Nancy
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Beskrivning
Inclusion Criteria:
- Adult individual who has received full information about the organization of the research and has not objected to the use of their data.
- Individual included in the TAC TIQUES database.
- Individual diagnosed with Lyme borreliosis (LB) at the time of their visit to the center or previously, regardless of the stage of LB (localized, early disseminated, or late disseminated).
- Individual with at least one follow-up consultation six months or more after the LB diagnosis (including cases of erythema migrans treated before the consultation at the Regional Reference Center for Tick-Borne Diseases).
Exclusion Criteria:
- Individual free of Lyme borreliosis (LB).
- Individual with a diagnosis of systemic or organ-specific autoimmune disease (AID) prior to the LB diagnosis.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: RETROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
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TACTIQUES
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Occurrence of an autoimmune disease during follow-up
Tidsram: up to six months
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Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated |
up to six months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Occurrence of an autoimmune disease during follow-up
Tidsram: through study completion, up to 4 years
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through study completion, up to 4 years
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Nature of the auto-immune disease
Tidsram: through study completion, up to 4 years
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through study completion, up to 4 years
|
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To assess the time to onset of an auto-immune disease after Lyme borreliosis
Tidsram: through study completion, up to 4 years
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through study completion, up to 4 years
|
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To identify factors associated with the occurrence of an autoimmune disease within six months following LB.
Tidsram: up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
|
up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Elisabeth BAUX, Department of Infectious Diseases, University Hospital of Nancy
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2025PI131-691
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Data collection is carried out at each center using a data collection form completed on an e-CRF.
The forms are stored for five years after the publication of the research results on a secure server specialized in health data (Epiconcept).
Data transfer between CHG de Villeneuve Saint Georges and CHRU de Nancy is performed via a virtual ticket allowing data retrieval, accessible for 24 hours.
Finally, data analysis is conducted in an Excel file on the server of the CHRU of Nancy
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