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临床试验/NCT01205464
NCT01205464已完成不适用

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

Linkoeping University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2005年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Improvement in persistent symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Doxycycline

Active Comparator

Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.

干预措施: Doxycycline (Drug)

Sugar pill

Placebo Comparator

Capsule Placebo, 200 mg, once daily, for 21 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Improvement in persistent symptoms

时间窗: 12 weeks

次要结局

  • Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO(12 weeks)

研究者

发起方
Linkoeping University
申办方类型
Other Gov

研究点 (1)

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