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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Nancy, Francia
- CHRU Nancy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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TACTIQUES
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Occurrence of an autoimmune disease during follow-up
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Occurrence of an autoimmune disease during follow-up
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
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up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elisabeth BAUX, Department of Infectious Diseases, University Hospital of Nancy
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2025PI131-691
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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