Status:
NOT_YET_RECRUITING
The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Lead Sponsor:
NYU Langone Health
Conditions:
Prosthetic-joint Infection
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study...
Eligibility Criteria
Inclusion
- Patients ages 18-90 years of age.
- Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
- Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision total joint arthroplasty (TJA) for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.
- Patients with prior PJI in the same joint that has recurred.
- Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent.
Exclusion
- Fungal PJI.
- Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal issue where there is concern for gut integrity.
- Severe acute gastrointestinal diseases (active bowel leak, acute colitis, acute pancreatitis).
- Active endocarditis.
- History of pancreatitis
- History of intolerance to probiotics.
- Patients that are pregnant or lactating.
- Immunocompromised patients and patients with immunosuppressive conditions (uncontrolled HIV, chemotherapy for cancer treatment, stem cell transplantation, immunosuppressive medications for solid organ transplant, systematic corticosteroid use, immunosuppressive medications for autoimmune dysfunction, and neonates).
- Patients who are critically ill.
- Revision TJA for aseptic reasons.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06919913
Start Date
April 1 2025
End Date
January 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016