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The Phenomenon of "Chronic Lyme"; an Observational Study

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ClinicalTrials.gov Identifier: NCT01151150
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by:
Sorlandet Hospital HF

Study Description
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Brief Summary:
The current study is set up to chart clinically and laboratory findings in Norwegian patients with symptoms attributed by themselves or their doctor to ongoing chronic Bb infection. Objectives is to assess laboratory findings in relation to established diagnostic criteria and to form a picture of the burden of symptoms and illness perception in this group of patients. The study is essentially exploratory, and is supposed to raise rather than to test hypotheses.

Condition or disease
Chronic Lyme Borreliosis

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

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Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Blood, CSF

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are eligible if they themselves or their physician suspected that they suffer from ongoing chronic Bb infection
Criteria

Inclusion Criteria:

  • Symptoms attributed by themselves or their doctor to ongoing chronic Bb infection

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151150


Locations
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Norway
Sølandet Hospital HF
Kristiansand, Norway, 4633
Sponsors and Collaborators
Sorlandet Hospital HF
South-Eastern Norway Regional Health Authority
More Information
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Responsible Party: Unn Ljøstad PhD, MD, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01151150    
Other Study ID Numbers: Chronic Lyme
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: June 2010
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Spirochaetales Infections
Tick-Borne Diseases