Actively Recruiting

Age: 18Years +
All Genders
ID06986265

Association of Cachexia and Gut Microbiome in Dialysis Patients: Study of Interactions with Uremic Toxins and Inflammation

Led by Université Catholique de Louvain · Updated on 2025-05-22

157

Participants Needed

2

Research Sites

152 weeks

Total Duration

On this page

Sponsors

U

Université Catholique de Louvain

Lead Sponsor

F

Fonds National de la Recherche Scientifique

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating cachexia, a common condition in patients with chronic kidney disease (CKD) undergoing dialysis, which is linked to higher illness and death rates. This research focuses on the role of the gut microbiome in CKD cachexia and how inflammation and uremic toxins contribute to this complex syndrome. The study aims to explore these connections and assess the impact of different dialysis doses and methods on cachexia. The study involves a prospective group of kidney failure patients receiving various forms of dialysis, including in-center, self-care in satellite units, home hemodialysis, and peritoneal dialysis. Participants will have detailed evaluations of cachexia and body composition, with collection of feces and blood samples to analyze gut microbiota, uremic toxins, and inflammatory markers. Measurements will be taken at the start, six months, and one year, including muscle strength and appetite assessments, with some patients undergoing muscle biopsies during surgical procedures. Participants will be followed longitudinally for about five years, with ongoing assessments of gut microbiota composition, inflammatory markers, uremic toxins, metabolomics profiles, dialysis dose and type, body composition, quality of life, handgrip strength, physical activity, and appetite. The study will compare cachectic and non-cachectic patients and examine differences among dialysis techniques. This comprehensive monitoring will help understand the interactions of these factors in CKD cachexia.

CONDITIONS

Brief Title

CKD Cachexia and Gut Microbiome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of kidney failure (stage V)
  • Maintenance dialysis for at least 3 months
  • Ability to understand trial procedures and comply with the protocol
Not Eligible

You will not qualify if you...

  • Severe nonadherence to dialysis procedure
  • Life expectancy less than 1 year
  • Chronic inflammatory digestive diseases such as Crohn's disease or ulcerative colitis
  • History of bariatric surgery
  • Active cancer
  • Pregnancy
  • Antibiotic use in the month before enrollment
  • Gastrointestinal surgery, colonoscopy, or probiotics use within 3 months before enrollment
  • Use of drugs affecting body composition started within 1 month (systemic corticosteroids, anabolic drugs, post-menopausal hormone therapy, injectable contraceptives)
  • Known endocrine disorders affecting metabolism treated or untreated for 1 month or less
  • Use of weight loss drugs such as GLP1 agonists or orlistat

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 5 years

Participants undergo collection of clinical data and biological samples including body weight, muscle mass, appetite assessments, bioelectrical impedance analysis, CT scans, feces collection for gut microbiota analysis, inflammation markers, and serum uremic toxins measurements.

Assessments at inclusion, 6 months, and 1 year with additional ongoing observations throughout the study

Trial Site Locations

Total: 2 locations

1

Cliniques universitaires Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

2

UCLouvain

Brussels, Belgium, 1200

Not Yet Recruiting

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Research Team

L

Laure Bindels, PhD

E

Eric Goffin, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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