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Study identifier: NCT07651462 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Preoperative Fasting and the Gut Microbiome Before Hip Replacement

Condition: Hip Osteoarthritis · Arthroplasty, Replacement, Hip · Postoperative Complications  ·  Sponsor: Charite University, Berlin, Germany

PhaseNA
Planned participants130
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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 index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-/B-/NK-cell subsets, activation/exhaustion 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). Adults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized…

This description comes directly from the study's public registry record.

Talk to the study team

Nele Wagener, Dr. med.  ·  +49 30 450 615076  ·  nele.wagener@charite.de

Always discuss trial participation with your own doctor first.

Locations (1)

Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin BerlinBerlin, State of Berlin, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT07651462