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Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ? (DOBI)

2026年9月22日更新者：Central Hospital, Nancy, France

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.

研究概览

地位

主动，不招人

条件

自动免疫疾病

研究类型

观察性的

注册 (估计的)

800

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Nancy、法国
    - CHRU Nancy

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：RETROSPECTIVE

团体/队列数

队列和干预

团体/队列
TACTIQUES

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Occurrence of an autoimmune disease during follow-up 大体时间：up to six months	Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated	up to six months

次要结果测量

结果测量	大体时间
Occurrence of an autoimmune disease during follow-up 大体时间：through study completion, up to 4 years	through study completion, up to 4 years
Nature of the auto-immune disease 大体时间：through study completion, up to 4 years	through study completion, up to 4 years
To assess the time to onset of an auto-immune disease after Lyme borreliosis 大体时间：through study completion, up to 4 years	through study completion, up to 4 years
To identify factors associated with the occurrence of an autoimmune disease within six months following LB. 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Central Hospital, Nancy, France

调查人员

首席研究员：Elisabeth BAUX、Department of Infectious Diseases, University Hospital of Nancy

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月1日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2026年11月30日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月23日

研究记录更新

最后更新发布 (实际的)