CKD Cachexia and Gut Microbiome

Recruiting

• Conditions: Chronic Kidney Diseases; Cachexia

• Registration Number: NCT06986265
• Lead Sponsor: Université Catholique de Louvain

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study Start: 2025-02-04
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-01
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composition and function of the gut microbiota	Throughout the entire study, approximately during 5 years	Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function

Secondary Outcome Measures

Name	Time	Method
Physical activity	Throughout the entire study, approximately during 5 years	International Physical Activity Questionnaire (IPAQ)
Appetite	Throughout the entire study, approximately during 5 years	Simplified Nutritional Assessment Questionnaire (SNAQ).
Level of inflammatory markers	Throughout the entire study, approximately during 5 years
Level of uremic toxins	Throughout the entire study, approximately during 5 years
Metabolomics profile	Throughout the entire study, approximately during 5 years
Dialysis dose	Throughout the entire study, approximately during 5 years	number of hours of dialysis per week
Dialysis modality	Throughout the entire study, approximately during 5 years	in-center hemodialysis vs self-care dialysis in a satellite unit vs home-hemodialysis vs peritoneal dialysis
Body composition	Throughout the entire study, approximately during 5 years	Noncontrast enhanced CT scan of the abdomen at the level of the third lumbar vertebra (L3)
Quality of life	Throughout the entire study, approximately during 5 years	FAACT (Functional Assessment of Anorexia-Cachexia Therapy) and FACIT (Functional Assessment of Chronic Illness Therapy - Fatigue Scale) questionnaires
Handgrip strength	Throughout the entire study, approximately during 5 years	Jamar dynamometer (in kg)

Trial Locations

Locations (2)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

UCLouvain; 🇧🇪 Brussels, Belgium