[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591887":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":33,"responsibleParty":65,"collaborators":67,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Université Catholique de Louvain","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dialysis patients",null,"Collection of clinical data and biological samples",[13],"Other: Collection of clinical data and biological sampling",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"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\u002FCachexia 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.",[9],[20],{"name":21,"affiliation":5,"role":22},"Inès Dufour, MD","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Laure Bindels, PhD","CONTACT","+32(2)7647337","laure.bindels@uclouvain.be",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Eric Goffin, MD","+32(2)7641855","eric.goffin@saintluc.uclouvain.be",[34,53],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cliniques universitaires Saint-Luc","RECRUITING","Brussels","1200","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.34878,50.85045,{"lat":45,"lon":44},[48,51,52],{"name":21,"role":26,"phone":49,"phoneExt":10,"email":50},"003227641855","ines.dufour@saintluc.uclouvain.be",{"name":30,"role":26,"phone":49,"phoneExt":10,"email":32},{"name":21,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":54,"status":55,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"UCLouvain","NOT_YET_RECRUITING",{"type":42,"coordinates":57},[44,45],{"lat":45,"lon":44},[60,62,64],{"name":25,"role":26,"phone":61,"phoneExt":10,"email":28},"+32 (2) 764 73 37",{"name":30,"role":26,"phone":63,"phoneExt":10,"email":32},"+32(2)764 18 55",{"name":21,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,70,73],{"name":69,"class":6},"Fonds National de la Recherche Scientifique",{"name":71,"class":72},"FRC- Fonds de la Recherche Clinique","UNKNOWN",{"name":74,"class":72},"SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation","100591887","ckd-cachexia-and-gut-microbiome-100591887",false,"NCT06986265","CKD Cachexia and Gut Microbiome","Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.","DYNAMICA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of kidney failure (stage V)\n* Maintenance dialysis for at least 3 months\n* Understanding of the trial procedures and ability to adhere to the trial protocol\n\nExclusion Criteria:\n\n* Severe nonadherence to the dialysis procedure\n* Life expectancy below 1 year\n* Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis)\n* Bariatric surgery\n* Active cancer\n* Pregnancy\n* Antibiotics consumption in the month preceding the inclusion\n* Gastro-intestinal surgery, colonoscopy, or probiotics consumption in the 3 months preceding the inclusion\n* Drugs influencing body composition initiated ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives.\n* Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands...\n* Patients under weight loss drugs : GLP1 agonists, orlistat","ALL","18 Years",{"count":86,"type":87},157,"ESTIMATED","OBSERVATIONAL","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.\n\nThe specific objectives are the followings:\n\n1. 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.\n2. 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).",[91,92],"Chronic Kidney Diseases","Cachexia",[94,95,96,97,98],"cachexia","Protein energy wasting","microbiota","chronic kidney disease","dialysis","2025-05-15",{"date":101,"type":102},"2025-05-22","ACTUAL",{"date":104,"type":102},"2025-02-04",{"date":106,"type":87},"2030-12",{"name":5,"class":6},2]