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NCT Number: NCT06986265

CKD Cachexia and Gut Microbiome

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).

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Key information

Conditions

Chronic Kidney Diseases Body Weight Body Weight Changes Cachexia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Thinness Urogenital Diseases Urologic Diseases Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of clinical data and biological sampling

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.

Primary outcomes

  1. Composition and function of the gut microbiota

    Time frame: 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 outcomes

  1. Level of inflammatory markers

    Time frame: Throughout the entire study, approximately during 5 years

  2. Level of uremic toxins

    Time frame: Throughout the entire study, approximately during 5 years

  3. Metabolomics profile

    Time frame: Throughout the entire study, approximately during 5 years

  4. Dialysis dose

    Time frame: Throughout the entire study, approximately during 5 years

    number of hours of dialysis per week

  5. Dialysis modality

    Time frame: 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

  6. Body composition

    Time frame: Throughout the entire study, approximately during 5 years

    Bioelectrical impedance analysis (in kg)

  7. Body composition

    Time frame: Throughout the entire study, approximately during 5 years

    Noncontrast enhanced CT scan of the abdomen at the level of the third lumbar vertebra (L3)

  8. Quality of life

    Time frame: 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

  9. Handgrip strength

    Time frame: Throughout the entire study, approximately during 5 years

    Jamar dynamometer (in kg)

  10. Physical activity

    Time frame: Throughout the entire study, approximately during 5 years

    International Physical Activity Questionnaire (IPAQ)

  11. Appetite

    Time frame: Throughout the entire study, approximately during 5 years

    Simplified Nutritional Assessment Questionnaire (SNAQ).

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Goffin, MD

CONTACT

[email protected]

+32(2)7641855

Laure Bindels, PhD

CONTACT

[email protected]

+32(2)7647337

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • FRC- Fonds de la Recherche Clinique
  • Fonds National de la Recherche Scientifique
  • SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation

Registry information

Official study title

Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.

Acronym: DYNAMICA

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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