Auto Immune DiseaseDOBINCT07837232
Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ?
An observational study of Auto Immune Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Auto Immune Disease
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Who may be able to join
- 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).
Who cannot join
- Individual free of Lyme borreliosis (LB).
- Individual with a diagnosis of systemic or organ-specific autoimmune disease (AID) prior to the LB diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Auto Immune Disease
- Keywords
- observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TACTIQUES | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of an autoimmune disease during follow-up
Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated
Measured: up to six months
Secondary outcomes (4)
Occurrence of an autoimmune disease during follow-up
Measured: through study completion, up to 4 years
Nature of the auto-immune disease
Measured: through study completion, up to 4 years
To assess the time to onset of an auto-immune disease after Lyme borreliosis
Measured: through study completion, up to 4 years
To identify factors associated with the occurrence of an autoimmune disease within six months following LB.
Measured: up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jan 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto Immune DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth BAUX, Principal investigator, Department of Infectious Diseases, University Hospital of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837232
- Sponsor's protocol ID
- 2025PI131-691
- Acronym
- DOBI
- Status last verified
- Nov 2025
- First submitted
- 4 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ?
- ClinicalTrials.gov ID
- NCT07837232
- Acronym / sponsor ID
- DOBI / 2025PI131-691
- Conditions
- Auto Immune Disease
- Keywords
- observational
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACTIQUES | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Individual free of Lyme borreliosis (LB).
- Individual with a diagnosis of systemic or organ-specific autoimmune disease (AID) prior to the LB diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of an autoimmune disease during follow-up
Time frame: up to six months
Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated
4 secondary outcomes
Occurrence of an autoimmune disease during follow-up
Time frame: through study completion, up to 4 years
Nature of the auto-immune disease
Time frame: through study completion, up to 4 years
To assess the time to onset of an auto-immune disease after Lyme borreliosis
Time frame: through study completion, up to 4 years
To identify factors associated with the occurrence of an autoimmune disease within six months following LB.
Time frame: up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth BAUX principal investigator
Department of Infectious Diseases, University Hospital of Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto Immune Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of an autoimmune disease during follow-up (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.