Clinical trial NCT02335437: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Official title: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue Syndrome, Chronic
Epstein-Barr Virus Infections
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 270
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Microbiological laboratories serving the population of Oslo and neighbour conties.

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


Eligibility 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

Primary outcomes:
measure: Fatigue
timeFrame: 6 monhts
measure: Steps per day
timeFrame: 6 monhts
Secondary outcomes:
measure: Pain threshold
timeFrame: 6 monhts
measure: Autonomic cardiovascular control
timeFrame: 6 monhts
measure: Cognitive function
timeFrame: 6 monhts
measure: Neuroendocrine markers
timeFrame: 6 monhts
measure: Immune markers
timeFrame: 6 monhts
measure: Bodily symptoms
timeFrame: 6 monhts
measure: Quality of life
timeFrame: 6 monhts
measure: Functional disability
timeFrame: 6 monhts
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Dept. of Pediatrics, Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Vegard B Wyller
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.