Fatigue Syndrome, ChronicCEBANCT02335437
Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
An observational study of Fatigue Syndrome, Chronic and Epstein-Barr Virus Infections, run by University Hospital, Akershus at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic, Epstein-Barr Virus Infections
- How many people
- 270 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Microbiological laboratories serving the population of Oslo and neighbour conties.
Who may be able to join
- 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
Who cannot join
- Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
- Pregnancy
- Debut of illness > 6 weeks ago
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Pediatrics, Akershus University Hospital
Lørenskog, Akershus, N-1478
About this study
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.
Read more
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
- Medical subject headings
- Fatigue Syndrome, Chronic, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute EBV infection | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Chalder fatigue questionnaire, total score
Measured: 6 monhts
Steps per day
Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)
Measured: 6 monhts
Secondary outcomes (8)
Pain threshold
Assessed by pressure algometry
Measured: 6 monhts
Autonomic cardiovascular control
Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.
Measured: 6 monhts
Cognitive function
Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.
Measured: 6 monhts
Neuroendocrine markers
In particular blood and urine measurements of catecholamines and the HPA axis
Measured: 6 monhts
Immune markers
In particular blood measurements of cytokines
Measured: 6 monhts
Bodily symptoms
Assessed by different questionnaires
Measured: 6 monhts
Quality of life
Assessed by the PedsQL inventory
Measured: 6 monhts
Functional disability
Assessed by the FDI inventory
Measured: 6 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Bruun Wyller, MD, PhD, University Hospital, Akershus
- Investigators
- Vegard B Wyller, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335437
- Sponsor's protocol ID
- CEBA
- Acronym
- CEBA
- Status last verified
- Jun 2017
- First submitted
- 7 Jan 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34987499Pedersen 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.
PubMed 30261303
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
- ClinicalTrials.gov ID
- NCT02335437
- Acronym / sponsor ID
- CEBA / CEBA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute EBV infection | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Microbiological laboratories serving the population of Oslo and neighbour conties.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
- Pregnancy
- Debut of illness > 6 weeks ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 6 monhts
Chalder fatigue questionnaire, total score
Steps per day
Time frame: 6 monhts
Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)
8 secondary outcomes
Pain threshold
Time frame: 6 monhts
Autonomic cardiovascular control
Time frame: 6 monhts
Cognitive function
Time frame: 6 monhts
Neuroendocrine markers
Time frame: 6 monhts
Immune markers
Time frame: 6 monhts
Bodily symptoms
Time frame: 6 monhts
Quality of life
Time frame: 6 monhts
Functional disability
Time frame: 6 monhts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 34987499Fevang 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.
- Derived from this study: PubMed 30261303Pedersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard B Wyller principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Syndrome, Chronic and Epstein-Barr Virus Infections, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 6 monhts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02335437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.