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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding probiotics to the standard treatment for prosthetic joint infection (PJI) of the hip and knee can improve immune system markers and reduce complications. The study aims to see if probiotics help lower inflammation markers, reduce medical and surgical problems, and improve gastrointestinal-related quality of life in patients treated for PJI. This interventional trial is sponsored by NYU Langone Health and involves adult patients diagnosed with PJI. Participants are randomly assigned to one of two groups: one group receives a probiotic supplement called Culturelle Digestive Daily Probiotic Capsule along with standard care, while the other group receives standard care alone. The probiotic contains 10 billion colony-forming units of Lactobacillus rhamnosus GG and is taken once daily by mouth for six weeks starting within 48 hours of beginning post-operative antibiotics. Standard care includes surgical and antibiotic treatments as planned for each patient. During the study, researchers measure changes in inflammation markers such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) at the start and six weeks after antibiotic therapy. They also evaluate patient-reported health outcomes related to joint function and overall wellbeing. Follow-up at 12 months includes monitoring complications, mortality, and gastrointestinal symptom questionnaires. The total study participation involves these assessments to understand the probiotic's impact alongside usual treatments for PJI.
CONDITIONS
Brief 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 to 90 years
- Diagnosis of prosthetic joint infection based on Musculoskeletal Infection Society criteria
- Planned surgical treatment with antibiotics for prosthetic joint infection, including debridement and implant retention or revision arthroplasty
- Patients with prior prosthetic joint infection in the same joint that has recurred
- Patients able to understand and willing to provide informed consent for probiotic use
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
- Intolerance to probiotics
- Pregnancy or lactation
- Immunocompromised conditions including uncontrolled HIV, cancer chemotherapy, stem cell transplantation, immunosuppressive medications, or neonates
- Critically ill patients
- Revision arthroplasty for non-infectious reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours post-surgery
Participants undergo planned surgical treatment for prosthetic joint infection, including debridement and implant retention or revision arthroplasty, followed by immediate post-operative care.
1 visit (in-person) for surgery and immediate care
Duration - 6 weeks post-operatively
Participants in the experimental group self-administer one probiotic capsule daily for 6 weeks post-operatively alongside standard antibiotic treatment. Participants in the control group receive standard care alone.
Weekly visits for up to 6 weeks
Duration - Up to 12 months post-surgery
Participants are monitored for medical and surgical complications, quality of life, and mortality related to prosthetic joint infection.
Approximately 3 visits over 12 months
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
D
Daniel Waren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here