Abstract
BackgroundAfter antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, also referred to as post-treatment Lyme disease syndrome. The reported prevalence of persistent symptoms varies considerably, and its pathophysiology is under debate. The LymeProspect study has been designed to investigate the prevalence, severity, and a wide range of hypotheses on the etiology of persistent symptoms among patients treated for Lyme borreliosis in the Netherlands.MethodsLymeProspect is a prospective, observational cohort study among adults with proven or probable Lyme borreliosis, either erythema migrans or disseminated manifestations, included at the start of antibiotic treatment. During one year of follow-up, participants are subjected to questionnaires every three months and blood is collected repeatedly during the first three months. The primary outcome is the prevalence of persistent symptoms after treatment, assessed by questionnaires online focusing on fatigue (CIS, subscale fatigue severity), pain (SF-36, subscale pain) and neurocognitive dysfunction (CFQ). Potential microbiological, immunological, genetic, epidemiological and cognitive-behavioral determinants for persistent symptoms are secondary outcome measures. Control cohorts include patients with long-lasting symptoms and unconfirmed Lyme disease, population controls, and subjects having reported a tick bite not followed by Lyme borreliosis.DiscussionThis article describes the background and design of the LymeProspect study protocol. This study is characterized by a prospective, explorative and multifaceted design. The results of this study will provide insights into the prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis, and may provide a rationale for preventive and treatment recommendations.Trial registrationNTR4998 (Netherlands Trial Register). Date of registration: 13 February 2015.
Highlights
After antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, referred to as post-treatment Lyme disease syndrome
Previous studies have described the prevalence of persistent symptoms attributed to Lyme borreliosis in the United States and in Europe
Persistence of Borrelia infection after antibiotic treatment has been suggested as a cause of persistent symptoms after treatment [34], this is difficult to detect with the current diagnostic tools, and randomized trials have not found beneficial effects of prolonged antibiotic treatment in patients with persistent symptoms [35,36,37,38]
Summary
Study design A multi-center prospective, observational cohort study with one year of follow-up is performed to determine the prevalence and severity of persistent symptoms after antimicrobial treatment for active Lyme borreliosis, and to assess determinants for development of these symptoms. In addition to online enrollment, study subjects as well as unconfirmed Lyme borreliosis controls are enrolled at the participating clinical expert centers For these patients, blood samples are collected and processed immediately after inclusion. From subjects in the unconfirmed Lyme borreliosis control group, blood is collected at baseline only These controls are subjected to the same measurements as the confirmed patients, with the exception of genetic analysis and skin biopsies, whereas for the population control group and the tick bite control group only questionnaire data are obtained. Secondary outcome measures are potential microbiological, immunological, genetic, clinical, cognitive-behavioral, and epidemiological determinants of persistent symptoms The association of these parameters with development of persistent symptoms is assessed by comparing results of confirmed Lyme borreliosis patients with persistent symptoms (cases) and without persistent symptoms (controls). When the prevalence of persistent symptoms would be higher, the power to detect these differences increases
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