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Идёт набор NCT06986265

CKD Cachexia and Gut Microbiome

— Наблюдательное Chronic Kidney Diseases Cachexia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Collection of clinical data and biological sampling.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases, Cachexia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

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

Обзор

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).

Вмешательства

  • Другое 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

Первичные конечные точки

  • Composition and function of the gut microbiota [Срок оценки: Throughout the entire study, approximately during 5 years]
Вторичные конечные точки (11)
  • Level of inflammatory markers [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Level of uremic toxins [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Metabolomics profile [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Dialysis dose [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Dialysis modality [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Body composition [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Body composition [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Quality of life [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Handgrip strength [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Physical activity [Срок оценки: Throughout the entire study, approximately during 5 years]
  • Appetite [Срок оценки: Throughout the entire study, approximately during 5 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 2 центра
  • Cliniques universitaires Saint-Luc — Brussels
  • UCLouvain — Brussels

Идентификаторы

NCT: NCT06986265 · B403202400099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗