Norwegian Science Studies – Lillestrøm Health Clinic: NO-CFS, stage 2, characterizing virus and immune function in patients with CFS. 2011 – 2012

In this blogpost I will give an introduction of the studyprotocol to the Lillestrøm Health Clinic stage II study named: “NO-CFS, stage 2, characterizing virus and immune function in patients with CFS” by Mette S. Johnsgaard, M.D., Norway. The study is ongoing and ends in 2012. This study has to be viewed as a pilot study. Thus, a power calculation cannot be performed. Data from this study can form the basis for future studies aimed at confirming possible findings. The study protocol is released and supervised by Norwegian National Committee for Ethics in Medical Research (REK).

The pathophysiology of CFS is not clear and highly debated. Studies aimed at identifying biomarkers for CFS patients may greatly benefit the identification of patients. Furthermore, insights into the pathophysiology of disease may facilitate novel therapies.

The primary aim for the stage II study are to identify possible pathogenic factors causing CFS through serological and virological studies and assess for possible deficiencies in immune cell function. Secondary aims are to identify biomarkers of disease through assessment of biological samples using flow cytometric procedures, metabolomics, multiplex analyses and ELISA.

Lillestrøm Health Clinic thesis is that CFS is caused by ongoing infections with retroviruses such as XMRV, or possibly other viruses of the herpes virus family, and possibly exacerbated by deficiencies in host immunity. Close relatives may or may not have a latent retroviral infection. We want to investigate and compare biological parameters and viral presence in extremely disabled patients, relatives, as well as non-related, matched healthy controls to gain insights into the pathophysiological mechanisms of disease in CFS patients. A concerted effort will be made to assess pathogens in patient blood, urine, and saliva samples, biomarkers in blood, as well as blood-derived immune cell phenotype and function.

Participants (patients and controls): Up to 100 individuals including pediatric CSF patients, who fit the criteria of the Canadian Consensus Criteria of 2003, will go through extensive blood work. All blood will be drawn in one setting and prepared for both research centers and blood bank. Patients will be recruited through Lillestrøm Health Clinic. We will include extremely disabled patients as well as patients with a less dysfunction.

We will include up to 100 controls, some healthy family members and some healthy people with no contact with CFS patients.

Science-team in the stage II study is collaborations with three research-specialists and two advisers:

 ⱱ Main investigator: Mette Sophie Johnsgaard, M.D. Medical director of Lillestrøm Health Clinic, Center for Treatment of Chronic Diseases, Norway.

 ⱱ Research: Assistant Prof. Dr. Yenan Bryceson. Center for Infectious Medicine, Department of Medicine, Karolinska Institute, Stockholm, Sweden. Specialist in cytotoxic lymphocyte biology, primary immunodeficiencies, haematological malignacies, molecular and cell biology.

 ⱱ Research: Dr. Med. Mauro Malnati. San Raffaele Scientific Institute, Milan, Italy. Physician, researcher and group leader In Human Virology. He is also a top expert in the design and validation of molecular diagnostic assays for human viruses (e.g.  HHV-6) based on TaqMan real-time PCR.

 ⱱ Research: Prof. Dr. Judy A. Mikovits. Former Whittemore-Peterson Institute (WPI). Specialist in XMRV virus, cancer, retrovirology, virology, molecular and cell biology. (note: the collaborations with Mikovits is ended)

 ⱱ Advisor: Prof. Dr. Med. Ola Didrik Saugstad. Professor of Pediatrics, Director of Department of Pediatric Research, Rikshospitalet, Medical Centre, Oslo University Hospital, Univ. of Oslo. World Renowned Neonatal. Specialist and WHO Advisor.

 ⱱ Advisor: Dr. Med. Asbjørg Stray-Pedersen. Att.physician, dr. med., Department for Medical Genetics, Oslo University Hospital, Rikshospitalet.

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Information about Lillestrøm Health Clinic:

Lillestrøm Health Clinic in Norway is a private health clinic specializing in the assessment, treatment, and research of chronic diseases such as chronic fatigue syndrome and myalgic encephalopathy/myelitis (ME), chronic digestive problems, fibromyalgia/chronic pain conditions, and more. Medical director of Lillestrøm Health Clinic. Center for Treatment of Chronic Diseases is Dr. med. Mette S. Johnsgaard.

Mette S. Johnsgaard M.D.  at Lillestrøm Health Clinic

 We work with national and international clinics, specialists and researchers. Our research is primarily carried out in laboratories in Norway, though qualified international laboratories are used when necessary. Our treatments focus on a holistic approach that includes nutritional advice and supplements.

 Our mission: We strive to be a leading institute for the treatment of chronic diseases, especially ME/CFS and fibromyalgia. Through cooperation with national and international researchers and clinics, we provide the best and most innovative services to our patients.

Our values: We treat relatives and patients with respect, dignity, and compassion in a safe and secure environment. We promise to give patients the best treatment available.

Research: Research into new and better treatments is an important and integral activity at the clinic.

Other services: Our secondary clinic offers private GP services, occupational health and a compliment of services such as nutrition counseling and therapy.

Treatment: Lillestrøm Health Clinic offers assessment and treatment of patients with individual attention to their situation and needs. Assessments and treatments are constantly changing based on clinical experience at the clinic, research results, and changes in the experiences of our partners, both in Norway and abroad.

Lillestrøm Health Clinic has collected expertise in the treatment of ME/CFS with well-known specialists. We use several types of drugs, in addition to a number of nutritional supplements and diets.

Lillestrøm Health Clinic uses only clinical laboratories that are quality assured. We also provide quick results to relevant tests.

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More from the study-protocol:

The prevalence of CFS is not clear, however, prevalence of CFS has been estimated to 0.3% of the population and is thought to affect three times as many women as men.

The etiology of CFS is still unknown. Wide ranging pathophysologically hypotheses have been put forth, including viral infections, immune aberration, host genetic factors, endocrine dysregulation, and psychiatric illness. A multifactor etiology has been considered, including both host and environmental factors. Considering the high prevalence and considerable morbidity of CFS, there is an urgent need for further scientific exploration aimed at gaining insights into the etiology and pathophysiology of CFS. Being able to better diagnose patients based on biomarkers and diagnostic tests would benefit patients and health care providers alike. Furthermore, this can facilitate understanding of disease and development of specific therapies.

At present, the dominant concept in regards to CFS is a pathophysiology caused by immune deregulation, often following a viral infection.

In relation to this, it is interesting to note that infection with herpes viruses can trigger potentially lethal immune dysregulation in individuals with inherited defects in cytotoxic lymphocytes which include natural killer (NK) cells and CD8+ T cells.

Conceivably, inherited, albeit relatively milder defects in immunity to intracellular pathogens may also be associated with disease in CFS patients. Recent progress in genetics and functional diagnostics have aided the identification and appropriate treatment of many primary immunodeficiency patients with defects in cytotoxic lymphocyte function.

Metabolic changes in severe CFS patients have not been studied in detail. The comprehensive quantitative assessment of plasma metabolites might bridge this information gap by depicting such functional information, as metabolite differences in plasma provide the closest link to cellular metabolism in the whole body. Thus, the extensive characterization of the largest possible number of metabolites from relevant or potentially impacted metabolic pathways is a promising approach.

Design and Method overview:

Table 1. Criteria for inclusion and exclusion

Table 2. Healthy controls: criteria for inclusion and exclusion

 

Participants (patients and controls): Up to 100 individuals including pediatric CSF patients, who fit the criteria of the Canadian Consensus Criteria of 2003, will go through extensive blood work. All blood will be drawn in one setting and prepared for both research centers and blood bank. Patients will be recruited through Lillestrøm Health Clinic. We will include extremely disabled patients as well as patients with a less dysfunction.

We will include up to 100 controls, some healthy family members and some healthy people with no contact with CFS patients.

Relevant questionnaires in this study (see also ref link to Information to Participants) :

1. Symptom assessments:

Karnofsky score

Canadian consensus criteria

Symptom assessment

2. Assessment relevant to etiology.

The start of symptoms/length of disability

Any relevant disorders before they became disabled

Any traveling: (Asia, Africa, south Europe, South America and North America, special attention to any disease acquired on these travels)

Genetics, how many relatives have autoimmune/chronic diseases

How many children and if or not they have following disease:

Allergies, digestion problems, ADHD, ADD, other chronic diseases.

Degree of self-assessed stress earlier on in life.

Vaccines

Any other relevant information that can explain any triggers, or lack of triggers.

 

Financing:

It is not given official government support for the project, mainly financed by Lillestrøm Health Clinic. Research participants have no financial expenses in connection with the study.

Reference:

Lillestrøm Health Clinic

Study Protocoll for Lillestrøm Health Clinic, Stage II_NO_CFS stage 2_characterizing virus and immune function in patients with CFS__LHK_2011

Personal communication/questions with Dr. Mette S. Johnsgaard regarding the study

Links:

Information to Participants (in norwegian, some in english): Forespørsel og informasjon om deltakelse i forskningsprosjektet_fase II_LHK

Karnofsky score

Canadian consensus criteria

Norwegian National Committee for Ethics in Medical Research (REK)

Norwegian Science Studies – Lillestrøm Health Clinic: The Norwegian study of CFS, NO-CFS, Stage 1: Confirmarory stydy for the detection on Gammaretrovirus related Gene Sequensces

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