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Preoperative Fasting and the Gut Microbiome Before Hip Replacement

RecruitingNAAges 18 Years - 75 YearsAllCharite University, Berlin, Germany
NCT07651462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This 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 i

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18-75 years (inclusive) * Scheduled for elective primary total hip arthroplasty (THA) * Able and willing to provide written informed consent * 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 Exclusion Criteria: * Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease) * Antibiotic therapy within the last 2 months before baseline (T0) * Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0) * Inability or unwillingness to provide informed consent * Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal/hepatic impairment, eating disorder) * BMI \< 18.5 kg/m² (underweight) * Concurrent participation in another interventional drug or device trial * Pregnancy or breastfeeding
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What it tests

  • Buchinger Fastenbox + intermittent fasting (20-day preoperative schedule)
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Where

1 site
Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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