RecruitingNCT06986265

CKD Cachexia and Gut Microbiome

Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.


Sponsor

Université Catholique de Louvain

Enrollment

157 participants

Start Date

Feb 4, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the connection between severe kidney disease (kidney failure requiring dialysis) and a condition called cachexia — severe unintentional weight loss and muscle wasting — and how changes in gut bacteria (the microbiome) may play a role. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage 5 kidney failure - You have been on maintenance dialysis for at least 3 months - You are able to understand and follow the study procedures **You may NOT be eligible if...** - You have a chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) - You have had bariatric (weight loss) surgery - You have active cancer - You are pregnant - You have taken antibiotics in the month before enrollment - You have had gut surgery, a colonoscopy, or used probiotics in the past 3 months - You recently started medications that affect body composition (steroids, testosterone, insulin, hormone therapy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCollection of clinical data and biological sampling

Multiple measures relevant to cachexia, such as body weight, body mass index (BMI), muscle mass (handgrip strength using a Jamar hand dynamometer, mid-upper arm muscle circumference), appetite (Functional Assessment of Anorexia/Cachexia Therapy \[FAACT\], Simplified Nutritional Appetite Questionnaire \[SNAQ\], Automated Self- Administered Dietary Assessment Tool \[ASA24\]) will be recorded at inclusion (T0), after 6 months (T6) and after one year of follow-up (T12). Body composition will be assessed by bioelectrical impedance analysis at T0, T6 and T12, and by CT-scan at T0 and T12. In parallel, gut microbiota composition on feces collection will be determined at the two time points (T0 and T12). Markers of systemic and intestinal inflammation will be assessed at T0 and T12. Serum levels of uremic toxins will be measured at T0 and T12. Human muscle biopsies will be performed at the time of a surgical intervention.


Locations(2)

Cliniques universitaires Saint-Luc

Brussels, Belgium

UCLouvain

Brussels, Belgium

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NCT06986265


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