Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Fatigue Syndrome, Chronic Clinical Trial

— CEBA  

Official title:

Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335437
• Other study ID #: CEBA
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: June 27, 2017
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Epstein-Barr Virus Infections
• Fatigue
• Fatigue Syndrome, Chronic
• Infection
• Virus Diseases

Locations

Country	Name	City	State
Norway	Dept. of Pediatrics, Akershus University Hospital	Lørenskog	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Chalder fatigue questionnaire, total score	6 monhts
Primary	Steps per day	Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)	6 monhts
Secondary	Pain threshold	Assessed by pressure algometry	6 monhts
Secondary	Autonomic cardiovascular control	Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.	6 monhts
Secondary	Cognitive function	Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.	6 monhts
Secondary	Neuroendocrine markers	In particular blood and urine measurements of catecholamines and the HPA axis	6 monhts
Secondary	Immune markers	In particular blood measurements of cytokines	6 monhts
Secondary	Bodily symptoms	Assessed by different questionnaires	6 monhts
Secondary	Quality of life	Assessed by the PedsQL inventory	6 monhts
Secondary	Functional disability	Assessed by the FDI inventory	6 monhts

External Links

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