Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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