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Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Aug 2025 to Aug 15, 2025
    • Site contacts updated at 2 of 2 sites
    v5
  3. Notable Start date: Jun 2025 to Aug 2025v4
  4. Notable Primary and study completion dates: Mar 2026 to Jun 2027
    • Start date: Feb 2025 to Jun 2025
    v3
  5. Notable Start date: Dec 2024 to Feb 2025
    • Primary and study completion dates: Dec 2025 to Mar 2026
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection. Despite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.
Trial Details
NCT Number NCT06636669
Lead Sponsor Boston Medical Center
Collaborators: American Association of Hip and Knee Surgeons
Conditions
(from sponsor)
Prosthetic-joint Infection, Dysbiosis
Related terms Dysbiosis, Reinfection, Surgical Wound Infection
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov