NCT06986265Recruiting
CKD Cachexia and Gut Microbiome
Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 157 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 4 Feb 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Université Catholique de Louvain
- Diseases
- Chronic kidney disease
- NCT number
- NCT06986265
What you commit to
- Study type: Observational
- Planned participants: 157
- From 4 Feb 2025 to the primary completion date, Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bariatric surgery
- Gastro-intestinal surgery, colonoscopy, or probiotics consumption in the 3 months preceding the inclusion
- Drugs influencing body composition initiated ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives.
- Patients under weight loss drugs : GLP1 agonists, orlistat
Other illness
- Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis)
- Active cancer
- Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands...
Other
- Severe nonadherence to the dialysis procedure
- Life expectancy below 1 year
- Pregnancy
- Antibiotics consumption in the month preceding the inclusion
Who the study is looking for
- Age ≥ 18 years
- Diagnosis of kidney failure (stage V)
- Maintenance dialysis for at least 3 months
- Understanding of the trial procedures and ability to adhere to the trial protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| UCLouvain Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.