Clinical trial NCT06986265: CKD Cachexia and Gut Microbiome
Official title: Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Cachexia
Keywords: cachexia
Protein energy wasting
microbiota
chronic kidney disease
dialysis
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
name: FRC- Fonds de la Recherche Clinique
name: SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
First posted: 2025-05-22
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Active cancer
* Pregnancy
* Antibiotics consumption in the month preceding the inclusion
* 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.
* Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands...
* Patients under weight loss drugs : GLP1 agonists, orlistat

Primary outcomes:
measure: Composition and function of the gut microbiota
timeFrame: Throughout the entire study, approximately during 5 years
Secondary outcomes:
measure: Level of inflammatory markers
timeFrame: Throughout the entire study, approximately during 5 years
measure: Level of uremic toxins
timeFrame: Throughout the entire study, approximately during 5 years
measure: Metabolomics profile
timeFrame: Throughout the entire study, approximately during 5 years
measure: Dialysis dose
timeFrame: Throughout the entire study, approximately during 5 years
measure: Dialysis modality
timeFrame: Throughout the entire study, approximately during 5 years
measure: Body composition
timeFrame: Throughout the entire study, approximately during 5 years
measure: Body composition
timeFrame: Throughout the entire study, approximately during 5 years
measure: Quality of life
timeFrame: Throughout the entire study, approximately during 5 years
measure: Handgrip strength
timeFrame: Throughout the entire study, approximately during 5 years
measure: Physical activity
timeFrame: Throughout the entire study, approximately during 5 years
measure: Appetite
timeFrame: Throughout the entire study, approximately during 5 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Brussels
country: Belgium
facility: UCLouvain
Study officials:
affiliation: Université Catholique de Louvain
name: Inès Dufour, MD
role: PRINCIPAL_INVESTIGATOR
References: