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ENROLLING BY INVITATION
NCT06636669
PHASE4

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

Sponsor: Boston Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Probiotic

Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.

OTHER

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