Chronic Fatigue SyndromeNCT00433355
Epstein-Barr Virus as a Possible Cause for Chronic Fatigue Syndrome
An observational study of Chronic Fatigue Syndrome, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 y/o and above with history of CFS matched those without as to age and gender.
Who may be able to join
- Healthy adults for controls.
- Adults with chronic fatigue syndrome.
Who cannot join
- Individuals with significant medical illness in reference to immunosuppressant drug.
- Note: We recruit participants in the Mississippi area who could come in our site to provide blood draw.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
About this study
Official title: Studies on Epstein-Barr Virus as a Possible Etiological Agent for Chronic Fatigue Syndrome
The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms occurring at the same time, but the cause is still unknown.
Read the detailed description
Epstein-Barr virus (EBV) is the etiological agent for heterophile positive infectious mononucleosis (IM). It is also an oncogenic herpes virus associated with African Burkitt's lymphoma (BL),nasopharyngeal carcinoma (NPC) and AIDS-associated B-cell lymphomas. EBV is also among a group of viruses that have been associated with chronic fatigue syndrome (CFS), although the etiology of CFS still remains unknown.Findings may lead to hypothesize that EBV enzymes, such as the dUTPase, have the capacity to induce immune dysregulation of the T-cell and NK cell responses and that this immune dysregulation produces immunopathology that results in the symptoms that we call CFS.
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome, Epstein-Barr Virus
- Medical subject headings
- Fatigue Syndrome, Chronic, Epstein-Barr Virus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Investigators
- Gailen D Marshall, M.D., PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433355
- Sponsor's protocol ID
- 2006-0265
- Status last verified
- Mar 2009
- First submitted
- 7 Feb 2007
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Epstein-Barr Virus as a Possible Etiological Agent for Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT00433355
- Acronym / sponsor ID
- 2006-0265
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome, Epstein-Barr Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Feb 2007 (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.
The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms occurring at the same time, but the cause is still unknown.
Detailed description
Epstein-Barr virus (EBV) is the etiological agent for heterophile positive infectious mononucleosis (IM). It is also an oncogenic herpes virus associated with African Burkitt's lymphoma (BL),nasopharyngeal carcinoma (NPC) and AIDS-associated B-cell lymphomas. EBV is also among a group of viruses that have been associated with chronic fatigue syndrome (CFS), although the etiology of CFS still remains unknown.Findings may lead to hypothesize that EBV enzymes, such as the dUTPase, have the capacity to induce immune dysregulation of the T-cell and NK cell responses and that this immune dysregulation produces immunopathology that results in the symptoms that we call CFS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 y/o and above with history of CFS matched those without as to age and gender.
Key inclusion criteria (2 listed)
- Healthy adults for controls.
- Adults with chronic fatigue syndrome.
Key exclusion criteria (2 listed)
- Individuals with significant medical illness in reference to immunosuppressant drug.
- Note: We recruit participants in the Mississippi area who could come in our site to provide blood draw.
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
Not reported in the source record.
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 19 Mar 2009.
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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.
Gailen D Marshall, M.D., PhD principal investigator
University of Mississippi Medical Center
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 Chronic Fatigue Syndrome, run by University of Mississippi Medical Center at 1 site in United States.
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 2 inclusion and 2 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 19 Mar 2009. 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 United States. 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.
Where can I read the original study information?
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 19 Mar 2009.