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The Phenomenon of "Chronic Lyme"; an Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 24, 2010
First Posted Date June 25, 2010
Last Update Posted Date July 26, 2011
Study Start Date May 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Phenomenon of "Chronic Lyme"; an Observational Study
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, CSF
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
Condition Chronic Lyme Borreliosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June¬†24,¬†2010)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01151150
Other Study ID Numbers Chronic Lyme
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Unn Ljøstad PhD, MD, Sorlandet Hospital HF
Study Sponsor Sorlandet Hospital HF
Collaborators South-Eastern Norway Regional Health Authority
Investigators Not Provided
PRS Account Sorlandet Hospital HF
Verification Date June 2010