Symptoms and General Pathology

All Conditions

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Rare Diseases

Syndrome

Fatigue

Fatigue Syndrome, Chronic

Muscular Diseases

Encephalomyelitis

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Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Anti-Infective Agents

All Drugs and Chemicals

Other Dietary Supplements

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for cancer fatigue, chronic fatigue