Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID03773003

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

Led by Universität des Saarlandes · Updated on 2025-05-29

150

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the underlying causes of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by analyzing blood lipids, metabolites, genetic information, and gut bacteria in patients with and without fatigue. They compare findings from patients with tumor disease both with fatigue and without fatigue, as well as healthy individuals matched by age and gender. The study also explores the possible benefits of probiotics in improving fatigue symptoms. Participants are randomly assigned to receive either probiotics containing various beneficial bacteria strains or a placebo made of corn starch. These probiotics include several types of Bifidobacterium, Lactobacillus, and Streptococcus species. The study groups include patients with tumor disease who have or do not have fatigue, and healthy control groups. The trial is single-blinded and involves administration of the probiotic or placebo. During the study, researchers collect and analyze samples for lipidomics, metabolomics, exome, and microbiome changes. Participants undergoing abdominal surgery may have samples taken from the peritoneal microbiome. Fatigue symptoms are assessed, with the main outcome measure being improvement in fatigue three months after chemotherapy ends. The study includes follow-up assessments to monitor changes and safety, with total participation lasting several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically, cytologically or radiologically confirmed tumor disease
  • Indication for chemotherapy
  • Written consent to participation
Not Eligible

You will not qualify if you...

  • Chronic-inflammatory bowel disease
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive either probiotics or placebo to investigate changes in fatigue and biological markers.

Regular visits during probiotic or placebo administration period

Follow-up

Duration - 3 months after end of chemotherapy

Participants are monitored for improvement of fatigue symptoms after the end of chemotherapy.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Saarland University Medical Center

Homburg, Saarland, Germany, 66424

Actively Recruiting

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Research Team

M

Michael Jelden, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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