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Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents (CEBA)

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ClinicalTrials.gov Identifier: NCT02335437
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Vegard Bruun Wyller, MD, PhD, University Hospital, Akershus

Brief Summary:

Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms. Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents undergoing acute EBV infection will be followed prospectively, and also compared with a group of healthy controls. The aim is twofold:

  • To identify factors that predispose to chronic fatigue among adolescents with acute EBV infection
  • To compare pathophysiological features of patients with acute EBV infection with a group of healthy controls.

Possible risk factors for chronic fatigue 6 months after EBV-infection includes:

  • Severity of the initial infection
  • Immune responses characteristics
  • Characteristics of the neuroendocrine stress response
  • Cognitive functioning
  • Emotional disturbances
  • Genetics/ epigenetics of candidate genes
  • Certain personality traits
  • Critical life events

Condition or disease
Fatigue Syndrome, Chronic Epstein-Barr Virus Infections

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Acute EBV infection
Healthy controls



Primary Outcome Measures :
  1. Fatigue [ Time Frame: 6 monhts ]
    Chalder fatigue questionnaire, total score

  2. Steps per day [ Time Frame: 6 monhts ]
    Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)


Secondary Outcome Measures :
  1. Pain threshold [ Time Frame: 6 monhts ]
    Assessed by pressure algometry

  2. Autonomic cardiovascular control [ Time Frame: 6 monhts ]
    Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.

  3. Cognitive function [ Time Frame: 6 monhts ]
    Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.

  4. Neuroendocrine markers [ Time Frame: 6 monhts ]
    In particular blood and urine measurements of catecholamines and the HPA axis

  5. Immune markers [ Time Frame: 6 monhts ]
    In particular blood measurements of cytokines

  6. Bodily symptoms [ Time Frame: 6 monhts ]
    Assessed by different questionnaires

  7. Quality of life [ Time Frame: 6 monhts ]
    Assessed by the PedsQL inventory

  8. Functional disability [ Time Frame: 6 monhts ]
    Assessed by the FDI inventory



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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Microbiological laboratories serving the population of Oslo and neighbour conties.
Criteria

Inclusion Criteria:

  • Age ≥ 12 years and < 20 years
  • Serological confirmation of acute EBV infection
  • Lives in one of the following Norwegian counties: Oslo, Akershus, Buskerud, Østfold, Vestfold

Exclusion Criteria:

  • Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
  • Pregnancy
  • Debut of illness > 6 weeks ago

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): NCT02335437


Locations
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Norway
Dept. of Pediatrics, Akershus University Hospital
Lørenskog, Akershus, Norway, N-1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Principal Investigator: Vegard B Wyller University Hospital, Akershus

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vegard Bruun Wyller, MD, PhD, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02335437     History of Changes
Other Study ID Numbers: CEBA
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Epstein-Barr Virus Infections
Fatigue Syndrome, Chronic
Fatigue
Virus Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases