[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505214":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":58,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PA Intervention","EXPERIMENTAL","The group which receives the PA as a dietary food supplement. A single capsule contains 500mg of sodiumpropionate, which is taken twice daily for 28 days.",[13],"Dietary Supplement: Sodium propionate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Intervention","PLACEBO_COMPARATOR","The control-group receives a placebo instead of propionate. The placebo contains maltodextrin and the same amount of sodium chloride as compared to the PA intervention. The placebo is taken twice per day for 28 days.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Sodium propionate","The patients will be randomized to PA or placebo intervention (2:1 randomization).\n\nAfter the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group).\n\nBy doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.",[9],null,{"type":6,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Johannes Holle, Dr. med.","CONTACT","004930450516012","johannes-benjamin.holle@charite.de",{"name":37,"role":33,"phone":34,"phoneExt":26,"email":38},"Nicola Wilck, Dr. med.","nicola.wilck@charite.de",[40],{"facility":41,"status":42,"city":43,"state":26,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin","RECRUITING","Berlin","13353","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],13.41053,52.52437,{"lat":51,"lon":50},[54,56],{"name":55,"role":33,"phone":26,"phoneExt":26,"email":26},"Johannes Holle, MD",{"name":57,"role":33,"phone":26,"phoneExt":26,"email":26},"Dominik Müller, MD",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Johannes Benjamin Holle","Principal Investigator",[63,65,67,69],{"name":64,"class":6},"University Hospital Heidelberg",{"name":66,"class":6},"University Hospital, Essen",{"name":68,"class":6},"University Hospital of Cologne",{"name":70,"class":6},"Universitätsklinikum Hamburg-Eppendorf","100505214","impact-of-propionic-acid-on-regulatory-t-cell-function-in-children-with-ckd-100505214",false,"NCT05858437","Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD","Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease","Pro-Kids","Inclusion Criteria:\n\n* Body weight: \\> 30kg\n* CKD G5 treated with hemodialysis\n* Continuous hemodialysis treatment for \\> 3 months\n* Clinical stable condition\n* Manifestation of CKD within childhood (\\\u003C18 years)\n\nExclusion Criteria:\n\n* Disease or dysfunctions, which disqualifies the patient\n* Incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study\n* Acute infections\n* Immunosuppressive therapy within the last 12 weeks before the start of the study\n* Pre-\u002Fpro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study\n* Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study\n* Malignant diseases\n* Pregnancy\n* chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease\n* alcohol- or drug abuse\n* parallel participation on other interventional trials","ALL","12 Years","20 Years",{"count":83,"type":84},16,"ESTIMATED","INTERVENTIONAL",[87],"NA","Pro-Kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.",[90],"CKD (Chronic Kidney Disease) Stage 5D","2025-02-14",{"date":93,"type":94},"2025-02-18","ACTUAL",{"date":96,"type":94},"2024-01-15",{"date":98,"type":84},"2026-04",{"name":5,"class":6},1]