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Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Sponsor: Boston Medical Center
Summary
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.
Official title: The Role of Peri-operative Adjunctive Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2025-08-15
Completion Date
2027-06
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
Probiotic
Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.
Standard of care
Standard of care (SOC) treatment includes surgery and antimicrobials.
Locations (2)
Boston Medical Center, Orthopedic Surgery
Boston, Massachusetts, United States
New York University Langone Orthopedics
New York, New York, United States