The Phenomenon of "Chronic Lyme"; an Observational Study

This study has been completed.
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01151150
First received: June 24, 2010
Last updated: July 25, 2011
Last verified: June 2010
  Purpose

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
Chronic Lyme Borreliosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Sorlandet Hospital HF:

Biospecimen Retention:   Samples With DNA

Blood, CSF


Estimated Enrollment: 30
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151150

Locations
Norway
Sølandet Hospital HF
Kristiansand, Norway, 4633
Sponsors and Collaborators
Sorlandet Hospital HF
South-Eastern Norway Regional Health Authority
  More Information

No publications provided

Responsible Party: Unn Ljøstad PhD, MD, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01151150     History of Changes
Other Study ID Numbers: Chronic Lyme
Study First Received: June 24, 2010
Last Updated: July 25, 2011
Health Authority: Norway: Sørlandet Hospital HF

Additional relevant MeSH terms:
Borrelia Infections
Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Tick-Borne Diseases

ClinicalTrials.gov processed this record on August 25, 2014