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

June 27, 2017 updated by: Vegard Bruun Wyller, MD, PhD, University Hospital, Akershus

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- Akershus
  - Lørenskog, Akershus, Norway, N-1478
    - Dept. of Pediatrics, Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Microbiological laboratories serving the population of Oslo and neighbour conties.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Healthy controls
Acute EBV infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Time Frame: 6 monhts	Chalder fatigue questionnaire, total score	6 monhts
Steps per day Time Frame: 6 monhts	Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)	6 monhts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain threshold Time Frame: 6 monhts	Assessed by pressure algometry	6 monhts
Autonomic cardiovascular control Time Frame: 6 monhts	Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.	6 monhts
Cognitive function Time Frame: 6 monhts	Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.	6 monhts
Neuroendocrine markers Time Frame: 6 monhts	In particular blood and urine measurements of catecholamines and the HPA axis	6 monhts
Immune markers Time Frame: 6 monhts	In particular blood measurements of cytokines	6 monhts
Bodily symptoms Time Frame: 6 monhts	Assessed by different questionnaires	6 monhts
Quality of life Time Frame: 6 monhts	Assessed by the PedsQL inventory	6 monhts
Functional disability Time Frame: 6 monhts	Assessed by the FDI inventory	6 monhts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Information on the project, including complete Study Protocol and Statistical Analysis Plan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria