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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01205464
Enrollment
15
Registered
2010-09-20
Start date
2005-02-28
Completion date
2008-02-29
Last updated
2010-09-20

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

Conditions

Cognitive Dysfunction, Fatigue, Paresis, Paresthesia, Radicular Pain

Keywords

Persistent symptoms, Doxycycline, Placebo, Neuroborreliosis

Brief summary

The aim of this randomised, double-blind crossover study was to determine whether Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the immune response and whether such an effect could influence the clinical outcome.

Detailed description

Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is currently no evidence for improvement of symptoms after repeated or prolonged antibiotic treatment. However, clinical observations have indicated that some patients improve during treatment with doxycycline (DOX), but regain the symptoms some time after completed treatment. This may be due to an immunomodulatory effect of the drug. The aim of this randomised, double-blind crossover study was to determine whether DOX has an impact on the persistent symptoms through alterations in the immune response and whether such an effect can influence the clinical outcome. A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were improvement of the persistent symptoms and physical and mental health, evaluated using the visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through physical examination with special emphasis on neurologic status at the follow-up visits. Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated cytokine responses.

Interventions

DRUGDoxycycline

Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.

DRUGPlacebo

Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* a history of adequately diagnosed and treated neuroborreliosis (presence of intrathecal borrelia-antibody production) * persistence of symptoms (with debut in conjunction with neuroborreliosis) of typical character, such as headache, radiculitis, cognitive dysfunction, fatigue, mood disorders, paresthesia or paresis \> 6 months post-treatment of neuroborreliosis

Exclusion criteria

* systemic immunosuppression (treatment with corticosteroids, cytostatics etc) * ongoing infection at inclusion * allergy against doxycycline * pregnancy * breast feeding * psychiatric disease * multiple sclerosis * rheumatoid arthritis * diabetes mellitus type 1 or II * inflammatory systemic diseases * liver ohc kidney dysfunction * treatment with didanosine, quinapril, antacids * malignancy

Design outcomes

Primary

MeasureTime frame
Improvement in persistent symptoms12 weeks

Secondary

MeasureTime frame
Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO12 weeks

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026