Actively Recruiting

Age: 18Years +
All Genders
NCT06986265

CKD Cachexia and Gut Microbiome

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

157

Participants Needed

2

Research Sites

303 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

Cachexia is common in patients with chronic kidney disease (CKD) and is associated with increased morbidity and mortality. Cachexia is a complex syndrome, in which inflammation and retention of uremic toxins are two main contributing factors. In this context, the role of the gut microbiome in CKD cachexia and the potential benefit of increasing the dialysis dose have been poorly explored. Here the investigators propose to study the links between cachexia and the gut microbiome, in association with inflammation and uremic toxins, in dialysis. The specific objectives are the followings: 1. Set up a prospective cohort of deeply characterized kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit and at home) and peritoneal dialysis, including evaluation of cachexia, body composition, collection of feces and blood to characterize the gut microbiota, measure serum levels of uremic toxins and inflammatory markers, with a longitudinal follow-up. 2. To compare cachectic versus non-cachectic dialysis patients in terms of gut microbiota, inflammatory markers, level of uremic toxins, muscle transcriptome, dialysis dose and modality. In a subgroup analysis, the investigators plan to compare the different techniques of dialysis (in-center vs home-hemodialysis vs peritoneal dialysis).

CONDITIONS

Official Title

CKD Cachexia and Gut Microbiome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E�3D 18 years
  • Diagnosis of kidney failure (stage V)
  • On maintenance dialysis for at least 3 months
  • Ability to understand trial procedures and follow the protocol
Not Eligible

You will not qualify if you...

  • Severe nonadherence to dialysis treatment
  • Life expectancy less than 1 year
  • Chronic inflammatory digestive diseases like Crohn's disease or ulcerative colitis
  • History of bariatric surgery
  • Active cancer
  • Pregnancy
  • Use of antibiotics within 1 month before joining
  • Gastrointestinal surgery, colonoscopy, or probiotics use within 3 months before joining
  • Use of drugs affecting body composition started �3C�3D 1 month ago: systemic corticosteroids, anabolic drugs (insulin, testosterone), post-menopausal hormone therapy, injectable contraceptives
  • Known endocrinological disorders causing hypo- or hypermetabolism, untreated or treated �3C�3D 1 month ago: thyroid or adrenal gland disorders
  • Use of weight loss drugs such as GLP1 agonists or orlistat

AI-Screening

AI-Powered Screening

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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

CONTACT

E

Eric Goffin, MD

CONTACT

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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