CKD Cachexia and Gut Microbiome

ConditionsChronic Kidney Diseases Cachexia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversité Catholique de Louvain

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe nonadherence to the dialysis procedure

Life expectancy below 1 year

Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis)

Bariatric surgery

Trial population

The patient population studied is adult kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit or at home) or with peritoneal dialysis for more than 3 months. The principal investigator, who is a Nephrologist and works at the Nephrology Department, in Cliniques universitaires Saint-Luc, in contact with dialysis patients, will check patient eligibility, collect the consent from the subjects who agree to participate and allocate an ID number.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Collection of clinical data and biological sampling
Other intervention
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.

Treatment groups

157 Participants

are divided into 1 treatment group

Group A: Dialysis patients1 intervention

Trial outcomes

Primary outcomes

Composition and function of the gut microbiota

Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function

Time frame