CKD Cachexia and Gut Microbiome

NCT ID: NCT06986265

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2030-12-31

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).

Conditions

Chronic Kidney Diseases; Cachexia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dialysis patients

Collection of clinical data and biological samples

Collection of clinical data and biological sampling

Intervention Type: OTHER

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.

Interventions

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 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds National de la Recherche Scientifique

OTHER

Sponsor Role: collaborator

FRC- Fonds de la Recherche Clinique

UNKNOWN

Sponsor Role: collaborator

SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation

UNKNOWN

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inès Dufour, MD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status: RECRUITING

UCLouvain

Brussels, , Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Laure Bindels, PhD

Role: CONTACT

laure.bindels@uclouvain.be

+32(2)7647337

Eric Goffin, MD

Role: CONTACT

eric.goffin@saintluc.uclouvain.be

+32(2)7641855

Facility Contacts

Inès Dufour, MD

Role: primary

ines.dufour@saintluc.uclouvain.be

003227641855

Eric Goffin, MD

Role: backup

eric.goffin@saintluc.uclouvain.be

003227641855

Laure Bindels, PhD

Role: primary

laure.bindels@uclouvain.be

+32 (2) 764 73 37

Eric Goffin, MD

Role: backup

eric.goffin@saintluc.uclouvain.be

+32(2)764 18 55

Other Identifiers

B403202400099

Identifier Type: -

Identifier Source: org_study_id