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Fatigue

Fatigue Syndrome, Chronic

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Chronic Graft Versus Host Disease

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Sulfalene

Acidophilus

Bifidobacterium

The administered probiotics are readily available on the market and contain

* Bifidobacterium breve, B. infantis, B. lactis, B. longum
* Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius
* Streptococcus thermophilus

Probiotics

Identically looking to verum, containing corn starch.

Placebo

Michael Jelden, MD

Michael Jelden, Dr.

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.

This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease with and without fatigue. These results will be compared to an age- and gender matched control group with a comparable tumor disease and to another age- and gender matched control group without tumor disease.

The investigators are following the same strategy for investigating an underlying pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age- and gender matched control group will be established from the beforementioned control group.

The investigators will also be screening for a peritoneal microbiome (possible correlate for leaky gut) in study patients undergoing abdominal surgery.

We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome by double-blinded, placebo-controlled administration of probiotics to the study population.

Double blinded, placebo controlled intervention with probiotics

There are three groups in the study:

1. Tumor disease with fatigue
2. Tumor disease without fatigue
3. Healthy control group

Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)

Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) by Lipidomics, Metabolomics, Microbiome and Exome Analysis and Investigation of Clinical Improvement Under Administration of Probiotics

Improvement of fatigue as measured by validated psychometric questionnaires.

University Hospital, Saarland

Principal Investigator

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Acute Graft Versus Host Disease

Vegard B Wyller

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

Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Chalder fatigue questionnaire, total score

Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)

Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.

Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.

In particular blood and urine measurements of catecholamines and the HPA axis

In particular blood measurements of cytokines

University Hospital, Akershus

Professor

The intervention consists of one introductory session (patients and their parents/next-of-kin), followed by 9 individual therapy sessions (one each week) of 1.5 hours duration and related home-work, combining elements from cognitive behavioural therapy and music therapy: Important elements of the mental training program are:

* Psychoeducation: Theories of CFS/ME pathophysiology and treatment rationale
* Relaxation: Bodily stress reduction, mindfulness
* Visualization: Contact with positive emotions, techniques of worrying reduction
* Experiences: Behavioral 'experiments' (individually adjusted), 'trick into action'
* Cognitive challenges: Challenging thoughts about disease process, stimulus and outcome expectancies, prognosis

Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.

Mental training

Vegard Bruun Wyller, PhD

The general aim of this study is to investigate the effect of an individually tailored mental training program in adolescents developing chronic fatigue syndrome (CFS) after an acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of disease mechanisms (autonomic, endocrine, and immune responses).

EBV-infection is a well-known trigger of CFS. A closely related research project (Chronic fatigue following acute Epstein-Barr virus infection in Adolescents; ClinicalTrials ID:NCT02335437) is a combined prospective and cross-sectional study of 200 adolescents suffering from acute EBV infection. The primary aim of that study is to identify factors that predispose to CFS 6 months after the acute infection. Thus, that project will provide a sample of thoroughly characterized CFS patients, all having the same precipitation factor (EBV-infection).

The present project is an intervention trial in the subgroup of patients that actually did develop CFS 6 months after the acute EBV infection. Patients will be randomised 1:1 to either a mental training program (10 sessions) combining elements from cognitive behavioral therapy and music therapy, or routine follow-up from the general practitioner. By its nature, treatment group allocation cannot be blinded; however, both patients and therapists will be blinded for end-point evaluation. An extensive investigational program will be carried out at three time points: Prior to the intervention, immediately after the intervention, and 1 year after the intervention. The program includes: Clinical examination; Pain threshold assessment; Cardiovascular assessment; Cognitive assessment; Sampling of biological material (blood and urine); Questionnaire; Brain fMRI; Qualitative interview; Monitoring of physical activity (accelerometer)

Mental Training for CFS Following EBV Infection in Adolescents

Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial

Mean steps/day during 7 consecutive days measured by accelerometer

An index of node centrality, based upon network analyses

Color-word interference test from the D-KEFS instrument

Functional connectivity analyses from resting state brain fMRI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)	NCT03773003	Cancer Related ... Fatigue Syndrom...	Probiotics Placebo	18 Years - 80 Years	Universität des Saarlandes
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)	NCT03773003	Cancer Related ... Fatigue Syndrom...	Probiotics Placebo	18 Years - 80 Years	Universität des Saarlandes
Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents	NCT02335437	Fatigue Syndrom... Epstein-Barr Vi...		12 Years - 20 Years	University Hospital, Akershus
Mental Training for CFS Following EBV Infection in Adolescents	NCT02499302	Fatigue Syndrom... Epstein-Barr Vi...	Mental training	12 Years - 20 Years	University Hospital, Akershus

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