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Can chronic virus infections cause Chronic Fatigue syndrome?
Note: The definitions used for this project will be the same as those
of Lombardi et al - the Fukuda-criteria (CDC 1994) and the Canadian
criteria (Carruthers et. al. 2003) with samples coming from an
established biobank. Other variables controlled for will be gene
expression and immunological markers. However, the project description
does not state whether disease stage will be one of the variables
controlled for.
The stated goal is to find agents or specific immunological findings
that can be directly connected with the diagnosis, so that it is
possible to develop laboratory tests to confirm the diagnosis.
Approximately 350 ME-patients will be included every year, and the
inclusion period is from 2010 to 2034. In total for the given time
span, the estimated number of participants is 15,000 giving the study
far more power than the very small studies done thus far. If new ideas
and new information about ME should surface during the project period,
the authors state that applications to the regional ethics committee
will be submitted to use the biobank-material for each new project.
=93Can chronic virus infections cause Chronic Fatigue syndrome?=94
Steering committee
Project leader and main supervisor: Prof. Emeritus Stig Jeansson
Supervisor and contact person: MD. Barbara Baumgarten-Austrheim (baba@uus.n=
o)
Supervisor: Dr. Oddbj=F8rn Brubakk (specialist in infectious diseases),
consultant at the ME/CFS-center at Oslo University Hospital, Ullev=E5l
Publication: The project is a doctoral study project for MD Barbara
Baumgarten-Austrheim. The results will be published in international
and national medical journals with peer-review.
Project start/end: The project started on the 1st of March 2010, and
will be ended by 29th of December 2034.
Goal: To study and find the causes of ME. A thematic biobank is being
established in a proper and safe way. The inclusion period is from
2010-2034. The project is part of the mission for the ME/CFS-center.
Short project description:
The cause of Myalgic Encephalopathy (ME) is still unknown. ME is
characterized by a debilitating chronic fatigue and defined additional
symptoms. About 70% of the cases are developed after an infection.
There is no specific diagnostic tests, and the diagnosis is set
clinically with the help of defined diagnostic criteria and exclusion
of other diseases that might explain the condition. Immunological
studies suggest an activation of the immune system, which might fit a
chronic infection.
The project has collaboration partners from St. George=92s University in
London (Cellular & Molecular Medicine), Uppsala University in Sweden
(Medical Genetics), Karolinska University Hospital (Center for
infectious medicine), Stockholm, Sweden and Department for
Microbiology at Oslo University Hospital, Ullev=E5l.
More about the goals for the study
1. We will determine the prevalence of XMRV in CFS patients and
matched controls. A possible relationship between XMRV infection and
the presence of other viruses that are often associated with CFS (e.g.
herpes viruses and enteroviruses) will be looked into.
2. a) Determine the prevalence of CIHHV-6 in CFS patients and matched
controls. If CIHHV-6 is found we will subtype virus as HHV-6A or
HHV-6B. The presence of free HHV-6 virus particles in plasma (viremia)
will be determined in CFS patients and matched controls.
2. b) Verify that HHV-7 activation is higher in CFS patients than in
controls and that a simultaneous activation of HHV-7 and HHV-6 is
found in CFS patients only. Hopefully be able to show that in a
subgroup of CFS patients a simultaneous active infection with these
viruses is a causal factor. Do CFS patients have an increased shedding
of HHV-7 in saliva?
3. We will determine the prevalence of chronic enterovirus infection
in CFS patients and a control group. If a reliable diagnosis of a
chronic enterovirus infection can be established in a subgroup of CFS
patients the possibility of antiviral treatment will be considered.
4. Immunological parameters will be evaluated in CFS patients and
healthy controls:
a. Various mediators of cytotoxic cell function.
b. Cytokine analyses
c. Gene-expression markers for immunological dysfunction
Diagnosis and patient selection
The project will use established international criteria for
ME-diagnostics: Fukuda-criteria (CDC 1994) and the Canadian criteria
(Carruthers et. al. 2003).
The diagnosis is made by an evaluation of the patient=92s medical
history, clinical evaluations and tests to ensure that the
condition/symptoms is not caused by other diseases. When a certain
ME-diagnosis is made, research has shown that patients can be divided
in 7 different subgroups based on their gene-expression pattern.
ME often debuts after a serious, acute infection, and signs of
immunological dysfunction is often seen. The part of the immune system
needed for an effective defense against viruses is often
down-regulated. We want to study different viruses as possible cause
for ME in certain subgroups. The virus discussed often leads to
lifelong chronic infections.
Examples of chronic viral infections such as the possible cause of ME:
XMRV and related gamma retrovirus:
In 2009, an HIV-like retroviruses, XMRV, found in ME patients in the
United States. XMRV possibly be a factor that contributes to the
development of ME. In 2010, in studies from Europe was not possible to
reproduce the XMRV virus found in ME. Despite this XMRV is still of
interest in ME. For work with such a retrovirus XMRV needed
competence. We collaborate with Prof. Jonas Blomberg, Department of
Clinical Virology, Institution of Medical Veten creator, Uppsala
University, who has studied retroviruses since the 70s.
(Even if XMRV proves to not be associated with human disease, it is
possible there are other as yet undiscovered retroviruses.)
Herpes viruses HHV-6 and HHV-7:
The group of Herpes Virus provides lifelong infections that may be
inactive, or be reactivated chronic. In ME Human Herpes Virus 6
(HHV-6) and Human Herpes Virus 7 (HHV-7) of interest. HHV-6 has two
subtypes, HHV-6A and HHV-6B. The presence of HHV-6A is low in the
normal population but relatively high in ME patients. By infection
with HHV-6A manufactured substances that down-regulates the immune
system. This may contribute to the spread of HHV-6A virus and give a
chronic infection.
Preliminary data suggest that an active HHV-6 infection with viremi
(virus in the blood) can only be detected in ME patients. It is shown
that HHV-6 can bind to DNA and was integrated into the chromosomes of
the egg and sperm. In this way, HHV-6 virus is inherited from parent
to child. Such chromosomal integrated HHV-6 (CIHHV-6) are found in all
body cells. Under 1 Assistant Professor Eric Frengen, Department of
Medical Genetics, University of Oslo, this must be seen as a carrier
status of the virus. We will investigate whether CIHHV-6 may be a
factor that contributes to the development of ME. Active infection
with HHV-6 and HHV-7 is only found in ME patients. If these viruses
are the cause of ME opens the possibility of antiviral therapy.
Enteroviruses:
Can chronic enterovirus infections cause ME? There are a large number
of different enteroviral infection with enteroviruses are common. Data
indicate that atypical enterovirus infections can occur in ME. An
atypical infection and an ineffective immune response can provide a
persistent enterovirus infection and inflammation of the tissues. If
evidence of chronic enterovirus infection can be detected in ME
patients, antiviral treatment possible.
For analysis of the presence of enteroviruses, Dr. Scient. Mona
Holberg-Petersen R & D Section, Microbiological Department, UUS
developed a sensitive and efficient real-time PCR to detect all
different enteroviruses. R & D department has all the equipment needed
for this work.
Informed consent will be required of patients who wished to be
evaluated for ME/CFS (myalgic encephalopathy/chronic fatigue syndrome)
and participate in the study.
The diagnosis is based on a set of clinical criteria that must be
fulfilled. The goal is to find agents or specific immunological
findings that can be directly connected with the diagnosis, so that it
is possible to develop laboratory tests to confirm the diagnosis. If a
defined virus infection causes ME in a defined subgroup, it may open
up the possibility of antiviral treatment with an effect on the
disease=92s development.
A control group will be established from blood donors matched both
regarding sex and age, from an assumed healthy normal population.
Biobank
The project is going to use material from a biobank that is being
established at the ME/CFS-center. This is a thematic biobank within
the ME-field, and will collect samples over a time span of
approximately 25 years.
For each patient, a control person matched by age and sex will be
sought from healthy blood donors.
Approximately 350 ME-patients will be included every year, and the
inclusion period is from 2010 to 2034.
In total for the given time span, the estimated number of participants
is 15.000.
If new ideas and new information about ME should surface during the
project period, applications to the regional ethics committee will be
submitted to use the biobank-material for each new project.
This biobank will also have value for international cooperation within
the field.
Some of the reasons for establishing such a large biobank is that
several subprojects will be carried out, and for each subproject a
relatively large number of samples must be used from the biobank. It
is desirable to research several scientific questions within the
ME/CFS-field.
Benefits and disadvantages of the project
Benefits for each project participant is a certain diagnosis of the
disease, with thorough evaluation.
If the background or causes of ME/CFS is established, this can lead to
possibilities for effective treatment for some patients.
It is a benefit for patients with a ME/CFS-diagnosis to get an
explanation of the mechanisms of the disease, and possible treatment
options.
For society the advantages are that the prevalence of ME/CFS in a
European population is about 0, 5% (ca. 20.000 cases in Norway).
Chronic diseases leads to large costs for society, and an improved
diagnosis and treatment will reduce those costs. Despite a vast
scientific work, many see ME/CFS as a mystic and controversial and
disease. Therefore it is important to establish clear and objective
measurable criteria for the diagnosis.
Disadvantages are that the collection of samples will take more of the
patient=92s time, and will not give immediate results for the patient.
It could also be a strain for the patient if hereditary factors for
ME-patients is detected.
ME-patients has been and still are an ignored group. The
ME/CFS-diagnosis is regarded as diffuse by health professionals. There
are no specific diagnostic tests or established treatment. In the
mission for the ME/CFS-center, research is an important part. In the
long term this project might contribute to better diagnostics and
treatment of the ME-disease.
A disadvantage might be that it can take a long time before improved
diagnostics and treatments are in place. Our judgment is that it is
time to try to improve the conditions for this patient group.
Decision from the ethical research committee
The project is approved by the research ethics committee, but must
fulfill special demands for example regarding approval from the Health
Directorate and approvement of ethics for each sub-project. The
establishing of the research biobank =93ME/CFS =96 Thematic Biobank=94 is
approved.
The full project application from the ME/CFS-center with the project
description and correspondence with the research ethics committee and
the approval of The Norwegian Biotechnology Advisory Board can be
found here in Norwegian:
http://lhkpasientfora.org/wp-content/uploads/2011/04/Prosjektbeskrivelse-ME=senteret.pdf
http://www.serendipitycat.no/?p=6101
The ME/CFS-center at Oslo
University Hospital, Ulleval ~
Large biomedical study of
ME/CFS and different viruses
(incl. XMRV)
by SerendipityCat
on
03. Apr, 2011 in Helse,
ME, Vitenskap og forskning
This is an English version of this post published
earlier today.
Maybe the best news for a long time for ME-patients
in this country – at least since the news about the
XMRV-study at Lillestrr
m Health Clinic
(
http://www.serendipitycat.no/?p=5833) – is that
the ME-center at UllevD
l (a subdivision
of Oslo
University Hospital) is doing large biomedical studies
of ME.
Today the patient blog “Pasientfora” has published
information (
http://lhkpasientfora.org/?p=2035)
about biomedical studies at the ME-center, and the
full project description, and I forward the information
to you with a summary, and with my own comments
at the end of this article.
Click the picture to visit the old webpages of the
ME/CFS-center (http://bit.ly/hrexGN
). The new
webpages (http://bit.ly/i4s84G
) found here – is
under construction. (Unfortunately the pages exist
only in Norwegian).
What is the ME/CFS-center?
The
ME/CFS-center was started at UllevD
l University
Hospital in Oslo Norway on the 1st of December,
2008 and offers a interdisciplinary team for adults
(over 18 years) with ME or chronic fatigue syndrom.
The center is led by MD Barbara Baumgarten-
Austrheim, and the team consists of a specialist in
infectious diseases, psychologist, occupational
therapist, physioterapist, clinical nutritionist and
social worker. They are recruiting more physicians.
The ME/CFS-center offers to diagnose patients, a
“second opinion”, courses on how to master to live
with the disease, thematic lectures for patients and
next of kin etc.
They also educate health professionals regarding the
disease, and has an outpatient team that travels to
the patient’s home if they are to sick to be
diagnosed/treated at the hospital.
The project – some facts
The ME/CFS-center is doing a biomedical research
project with the following scientific title:
“Can chronic virus infections
cause Chronic Fatigue syndrome?”
The
full project description can be found here.
(http://bit.ly/fEMgRM
) (Some of the document is in
Norwegian, but there is a project description in
English).
Steering committee
Project leader and main supervisor: Prof. Emeritus
Stig Jeansson (s.l.jeansson@medisin.uio.no)
Supervisor and contact person: MD. Barbara
Baumgarten-Austrheim (baba@uus.no)
Supervisor: Dr. Oddbjr
rn Brubakk
(specialist in
infectious diseases), consultant at the
ME/CFS-center at Oslo University Hospital, UllevD
l
Publication: The project is a doctoral study project
for MD Barbara Baumgarten-Austrheim. The results
will be published in international and national
medical journals with peer-review.
Project start/end: The project started on the 1st of
March 2010, and will be ended by 29th of December
2034.
Goal: To study and find the causes of ME. A thematic
biobank is being establish in a proper and safe way.
The inclusion period is from 2010-2034. The project
is part of the mission for the ME/CFS-center.
Short project description: The cause of Myalgic
Encephalopathy (ME) is still unknown. ME is
characterised by a debilitating chronic fatigue and
defined additional symptoms. About 70% of the
cases are developed after an infection. There is no
specific diagnostic tests, and the diagnosis is set
clinically with the help of defined diagnostic criteria
and exclusion of other diseases that might explain
the condition. Immunological studies suggest an
activation of the immune system, which might fit a
chronic infection.
The project has collaboration partners from St.
George’s University in London (Cellular & Molecular
Medicine), Uppsala University in Sweden (Medical
Genetics), Karolinska University Hospital (Center for
infectious medicine), Stockholm, Sweden and
Department for Microbiology at Oslo University
Hospital, UllevD
l.
Co-workers and their role in the project:
Amanuensis Dr. Eirik Frengen. Institute of
Medical Genetics, Oslo University Hospital,
UllevD
l.
Responsible for studies of human
herpesvirus-6 integrated in the human
chromosome.
Chief Engineer Mona Holberg-Petersen.
Department of Microbiology, Oslo University
Hospital, UllevD
l.
Responsible for molecularbiological
analysis.
Professor Jonas Blomberg, Department of
Medical Science, Clinical Virology, Uppsala
University, Sweden
Responsible for analysing XMRV-virus.
Professor Jonathan R. Kerr, Department for
cellular and molecular medicine, St.
George’s University of London.
Responsible for studying subgroups of
ME/CFS-patients.
Researcher Yenan T. Bryceson, Center
Infectious Medicine, Karolinska University
Hospital, Stockholm, Sweden.
Responsible for immunological
analysis.
More about the goals for the study
1. We
will determine the prevalence of XMRV in CFS
patients and matched controls. A possible
relationship between XMRV infection and the
presence of other viruses that are often associated
with CFS (e.g. herpesviruses and enteroviruses) will
be looked into.
2. a) Determine the prevalence of CIHHV-6 in CFS
patients and matched controls. If CIHHV-6 is found
we will subtype virus as HHV-6A or HHV-6B. The
presence of free HHV-6 virus particles in plasma
(viremia) will be determined in CFS patients and
matched controls.
2. b) Verify that HHV-7 activation is higher in CFS
patients than in controls and that a simultaneous
activation of HHV-7 and HHV-6 is found in CFS
patients only. Hopefully be able to show that in a
subgroup of CFS patients a simultaneous active
infection with these viruses is a causal factor. Do
CFS patients have an increased shedding of HHV-7 in
saliva?
3. We will determine the prevalence of chronic
enterovirus infection in CFS patients and a control
group. If a reliable diagnosis of a chronic enterovirus
infection can be established in a subgroup of CFS
patients the possibility of antiviral treatment will be
considered.
4. Immunological parameters will be evaluated in
CFS patients and healthy controls:
a. Various mediators of cytotoxic cell function.
b. Cytokine analyses
c. Gene-expression markers for immunological
dysfunction
Diagnosis and patient selection
The
project will use established international criteria
for ME-diagnostics: Fukuda-criteria (CDC 1994) and
the Canadian criteria (Carruthers et. al. 2003).
The diagnosis is made by an evaluation of the
patient’s medical history, clinical evaluations and
tests to ensure that the conditon/symptoms is not
caused by other diseases. When a certain
ME-diagnosis is made, research has shown that
patients can be divided in 7 different subgroups
based on their gene-expression pattern.
ME often debuts after a serious, acute infection, and
signs of immunological dysfunction is often seen.
The part of the immune system needed for an
effective defence against viruses is often
down-regulated. We want to study different viruses
as possible cause for ME in certain subgroups. The
virus discussed often leads to lifelong chronic
infections.
You can read more about the different viruses to be
studied in the project description, or at Pasientfora.
Patients who wished to be evaluated for ME/CFS
(myalgic encephalopaty/chronic fatigue syndrome)
will participate in the study with informed consent.
The diagnosis is based on a set of clinical criteria
that must be fulfilled. It is a need to find agents or
specific immunological findings that can be directly
connected with the diagnosis, so that it is possible
to develop laboratory tests to confirm the diagnosis.
If a defined virus infection causes ME in a defined
subgroup, it may open up the possibility of antiviral
treatment with an effect on the disease’s
development.
A controlgroup will be established from blood donors
matched both regarding sex and age, from an
assumed healthy normal population.
Biobank
The project is going to use material from a biobank
that is being established at the ME/CFS-center. This
is a thematic biobank within the ME-field, and will
collect samples over a timespan of approximately 25
years.
For each patient, a control person matched by age
and sex will be sought from healthy blood donors.
Approximately 350 ME-patients will be included every
year, and the inclusion period is from 2010 to 2034.
In total for the given timespan, the estimated
number of participants is 15.000.
If new ideas and new information about ME should
surface during the project period, applications to the
regional ethics committe will be submitted to use
the biobank-material for each new project.
This biobank will also have value for international
cooperations within the field.
Some of the reasons for establishing such a large
biobank, is that several subprojects will be carried
out, and for each subproject a relatively large
number of samples must be used from the biobank.
It is desirable to research several scientific questions
within the ME/CFS-field.
Benefits and disadvantages of the project
Benefits for each project participant is a certain
diagnosis of the disease, with thorough evaluation.
If the background or causes of ME/CFS is
established, this can lead to possibilities for
effective treatment for some patients.
It is a benefit for patients with a ME/CFS-diagnosis
to get an explanation of the mechanisms of the
disease, and possible treatment options.
For society the advantages are that the prevalence
of ME/CFS in an European population is about 0,5%
(ca. 20.000 cases in Norway). Chronic diseases leads
to large costs for society, and an improved diagnosis
and treatment will reduce those costs. Despite a
vast scientific work, many see ME/CFS as a mystic
and controversial and disease. Therefore it is
important to establish clear and objective
measurable criteria for the diagnosis.
Disadvantages is that the collection of samples will
take more of the patient’s time, and will not give
immediate results for the patient.
It can be a strain for the patient if hereditary factors
for ME-patients is detected.
ME-patients has been and still are an ignored group.
The ME/CFS-diagnosis is regarded as diffuse by
health professionals. There are no specific diagnostic
tests or established treatment. In the mission for
the ME/CFS-center, research is an important part. In
the long term this project might contribute to better
diagnostics and treatment of the ME-disease.
A disadvantage might be that it can take a long time
before improved diagnostics and treatments are in
place. Our judgement is that it is time to try to
improve the conditions for this patient group.
Decision from the ethical research committe
The project is approved by the research ethics
committee, but must fulfill special demands for
example regarding approval from the Health
Directorate and approvement of ethics for each
sub-project. The establishing of the research biobank
“ME/CFS – Thematic Biobank” is approved.
The full project application from the ME/CFS-center
with the project description and correspondence with
the research ethics committe and the approval of The
Norwegian Biotechnology Advisory Board can be
found here: Project description ME/CFS-center
(
http://bit.ly/fEMgRM
)
My comments
I
have not had the opportunity to read the full
project description, but wants to than Pasientfora for
making it available and giving us a summary of the
project.
I think this sounds like a solid, comprehensive and
exiting project. I am especially glad that a biobank
now is established with samples (blood and hair)
from ME-patients, and that it is highlighted that this
also will be useful in international research
collaborations.
The project will study the relation between ME/CFS
and several viruses, amongst them XMRV. They are
also open to that new information and new ideas in
the ME research-field will be actualised during the
project period, and are willing and ready to include
these in new sub-projects. This is very positive.
This is also of course a clear and solid statement
that the ME/CFS-center takes the disease seriously
and really wants to research in depth to find the
causes of this disease, and also possible treatments,
for example antiviral treatments. We have not seen
a biomedical research effort of this magnitude here
in Norway before, and to my knowledge such an
extensive and long-term project has not been carried
out anywhere else either.
Together with the XMRV-research being carried out at
Lillestrr
m Helath Clinic
in cooperation with the WPI
and the San Raffaele-institute, Norway will be
positioned in a positive way regarding biomedical
research of the causes of ME/CFS. Uppsala University
is as we know already involved in XMRV-research,
and I’m glad to hear that they will cooperate with
the ME/CFS-center in this project.
All in all this was a very positiv reading of the
project description served to us on a Sunday
afternoon, and I think we have reason to thank
Barbara and the others at the ME/CFS-center for their
effort for the research and the patients.
Wishing you all a happy Sunday!