NCT02335437

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

January 7, 2015

Last Update Submit

June 27, 2017

Conditions

Fatigue Syndrome, ChronicEpstein-Barr Virus Infections

Outcome Measures

Primary Outcomes (2)

  • Fatigue

    Chalder fatigue questionnaire, total score

    6 monhts

  • Steps per day

    Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)

    6 monhts

Secondary Outcomes (8)

  • Pain threshold

    6 monhts

  • Autonomic cardiovascular control

    6 monhts

  • Cognitive function

    6 monhts

  • Neuroendocrine markers

    6 monhts

  • Immune markers

    6 monhts

  • +3 more secondary outcomes

Study Arms (2)

Acute EBV infection

Healthy controls

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Microbiological laboratories serving the population of Oslo and neighbour conties.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

Location

Related Publications (2)

  • Fevang B, Wyller VBB, Mollnes TE, Pedersen M, Asprusten TT, Michelsen A, Ueland T, Otterdal K. Lasting Immunological Imprint of Primary Epstein-Barr Virus Infection With Associations to Chronic Low-Grade Inflammation and Fatigue. Front Immunol. 2021 Dec 20;12:715102. doi: 10.3389/fimmu.2021.715102. eCollection 2021.

    PMID: 34987499DERIVED

  • Pedersen M, Asprusten TT, Godang K, Leegaard TM, Osnes LT, Skovlund E, Tjade T, Oie MG, Wyller VBB. Predictors of chronic fatigue in adolescents six months after acute Epstein-Barr virus infection: A prospective cohort study. Brain Behav Immun. 2019 Jan;75:94-100. doi: 10.1016/j.bbi.2018.09.023. Epub 2018 Sep 25.

    PMID: 30261303DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, ChronicEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Vegard B Wyller

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

NO(1)