Actively Recruiting
The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Led by NYU Langone Health · Updated on 2026-03-04
152
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.
CONDITIONS
Official Title
The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients ages 18-90 years
- Diagnosis of prosthetic joint infection (PJI) based on Musculoskeletal Infection Society criteria
- Planned treatment with surgical debridement, antibiotics, implant retention, or revision total joint arthroplasty for PJI with anticipated discontinuation of antibiotics
- Patients with prior PJI in the same joint that has recurred
- Ability to understand probiotic benefits and risks and provide informed consent
You will not qualify if you...
- Fungal prosthetic joint infection
- Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal issues affecting gut integrity
- Severe acute gastrointestinal diseases such as active bowel leak, acute colitis, or acute pancreatitis
- Active endocarditis
- History of pancreatitis
- History of intolerance to probiotics
- Pregnant or lactating patients
- Immunocompromised patients or those with immunosuppressive conditions including uncontrolled HIV, cancer chemotherapy, stem cell transplantation, immunosuppressive medications for organ transplant or autoimmune dysfunction, and neonates
- Critically ill patients
- Revision total joint arthroplasty for aseptic reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
R
Ran Schwarzkopf, MD
CONTACT
D
Daniel Waren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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