Exploring the relationship between gut microbiome and cachexia in chronic kidney disease patients
Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
This study looks at how the gut bacteria might affect weight loss and muscle wasting in people with chronic kidney disease who are on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université Catholique de Louvain Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT06986265 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the links between cachexia and the gut microbiome in patients with chronic kidney disease (CKD) undergoing dialysis. It will establish a prospective cohort of patients receiving various forms of dialysis, including hemodialysis and peritoneal dialysis. Researchers will collect clinical data, biological samples, and assess body composition, inflammatory markers, and uremic toxins over time to better understand the role of the gut microbiome in CKD cachexia.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stage V kidney failure who have been on maintenance dialysis for at least three months.
Not a fit: Patients with severe nonadherence to dialysis, active cancer, or chronic inflammatory diseases of the digestive tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for cachexia in CKD patients, potentially enhancing their quality of life and survival rates.
How similar studies have performed: While the role of the gut microbiome in CKD cachexia has been poorly explored, similar studies in other conditions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels and 1 other locations
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- UCLouvain — Brussels, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Inès Dufour, MD — Université Catholique de Louvain
- Study coordinator: Laure Bindels, PhD
- Email: laure.bindels@uclouvain.be
- Phone: +32(2)7647337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.