CKD Cachexia and Gut Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of clinical data and biological sampling.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
Overview
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).
Interventions
- Other Collection 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 asse
Primary outcome measures
- Composition and function of the gut microbiota [Time frame: Throughout the entire study, approximately during 5 years]
Secondary outcome measures (11)
- Level of inflammatory markers [Time frame: Throughout the entire study, approximately during 5 years]
- Level of uremic toxins [Time frame: Throughout the entire study, approximately during 5 years]
- Metabolomics profile [Time frame: Throughout the entire study, approximately during 5 years]
- Dialysis dose [Time frame: Throughout the entire study, approximately during 5 years]
- Dialysis modality [Time frame: Throughout the entire study, approximately during 5 years]
- Body composition [Time frame: Throughout the entire study, approximately during 5 years]
- Body composition [Time frame: Throughout the entire study, approximately during 5 years]
- Quality of life [Time frame: Throughout the entire study, approximately during 5 years]
- Handgrip strength [Time frame: Throughout the entire study, approximately during 5 years]
- Physical activity [Time frame: Throughout the entire study, approximately during 5 years]
- Appetite [Time frame: Throughout the entire study, approximately during 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 2 centers
- Cliniques universitaires Saint-Luc — Brussels
- UCLouvain — Brussels
Identifiers
NCT: NCT06986265 · B403202400099