[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641421":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":33,"whyStopped":18,"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},"Preoperative Fasting (20 days; Buchinger Fastenbox + intermittent fasting)","EXPERIMENTAL","Adults aged 18-75 scheduled for elective primary total hip arthroplasty follow a structured 20-day preoperative fasting schedule self-administered at home with study-team supervision. Schedule: Day -20 to -16 - Buchinger Fastenbox (5 days); Day -15 to -11 - intermittent fasting (5 days); Day -10 to -6 - Buchinger Fastenbox (5 days); Day -5 to -1 - intermittent fasting (5 days). No fasting is performed post-operatively. Daily self-monitored ketones, weight, waist circumference, and blood pressure are recorded throughout the fasting window. All other perioperative care follows the standard institutional protocol.",[13],"Other: Buchinger Fastenbox + intermittent fasting (20-day preoperative schedule)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Preoperative Care","NO_INTERVENTION","Adults aged 18-75 scheduled for elective primary total hip arthroplasty receive routine preoperative care according to the institutional standard at Charité Centrum für Muskuloskeletale Chirurgie. No fasting protocol is provided as part of the study. Continuous glucose monitoring and daily weight, waist circumference, and blood pressure are recorded during the same pre-operative window as the fasting arm. Stool and blood samples are collected at the same study time points as the fasting arm.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Buchinger Fastenbox + intermittent fasting (20-day preoperative schedule)","Two 5-day cycles of the Buchinger Wilhelmi Fastenbox (hypocaloric, low-carbohydrate, plant-based vegetable broths) alternating with two 5-day cycles of intermittent fasting (time-restricted feeding), totaling 20 days immediately preceding surgery. Self-administered at home; participants receive structured instructions, daily symptom and metabolic logs, and contact options with the study team for the duration of each cycle.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Nele Wagener, Dr. med.","CONTACT","+49 30 450 615076","nele.wagener@charite.de",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],13.41053,52.52437,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. med. Nele Wagener","Principal Investigator",[52,54],{"name":53,"class":6},"Schulthess Klinik",{"name":55,"class":56},"Buchinger Wilhelmi Clinic","UNKNOWN","100641421","preoperative-fasting-and-the-gut-microbiome-before-hip-replacement-100641421",false,"NCT07651462","Preoperative Fasting and the Gut Microbiome Before Hip Replacement","Preoperative Metabolic Optimization: Influence of Intermittent and Buchinger-Type Fasting on the Gut Microbiome, Immune Profile, and Postoperative Complications in Patients Undergoing Primary Total Hip Arthroplasty - A Randomized Controlled Trial","PreFAST-Hip","Inclusion Criteria:\n\n* Adults aged 18-75 years (inclusive)\n* Scheduled for elective primary total hip arthroplasty (THA)\n* Able and willing to provide written informed consent\n* Able to follow the 20-day preoperative fasting protocol independently at home (if randomized to the fasting arm) or willing to be randomized to either arm\n\nExclusion Criteria:\n\n* Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease)\n* Antibiotic therapy within the last 2 months before baseline (T0)\n* Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0)\n* Inability or unwillingness to provide informed consent\n* Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal\u002Fhepatic impairment, eating disorder)\n* BMI \\\u003C 18.5 kg\u002Fm² (underweight)\n* Concurrent participation in another interventional drug or device trial\n* Pregnancy or breastfeeding","ALL","18 Years","75 Years",{"count":69,"type":70},130,"ESTIMATED","INTERVENTIONAL",[73],"NA","Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters.\n\nThis single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-\u002FB-\u002FNK-cell subsets, activation\u002Fexhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay).\n\nAdults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h \u002F 24 h \u002F 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.",[76,77,78,79,80],"Hip Osteoarthritis","Arthroplasty, Replacement, Hip","Postoperative Complications","Surgical Wound Infection","Gastrointestinal Microbiome",[82,83,84,85,86,87,88,89,90],"Therapeutic fasting","Buchinger fasting","Intermittent fasting","Gut microbiome","Immunophenotyping","Continuous glucose monitoring","Total hip arthroplasty","Metabolic syndrome","Preoperative optimization","2026-06-17",{"date":93,"type":94},"2026-06-22","ACTUAL",{"date":96,"type":94},"2025-07-01",{"date":98,"type":70},"2026-12-31",{"name":5,"class":6},1]