The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Purpose
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.
Condition
- Prosthetic-joint Infection
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Probiotic supplementation + Standard of care |
Patients will receive their first dose of the probiotic within 48 hours of starting post-operative antibiotic treatment. The probiotic is continued for the initial 6 weeks of antibiotic treatment in addition to standard of care (SOC). |
|
|
No Intervention Standard of care alone |
Patients do not receive any additional treatment and undergo SOC treatment. |
|
Recruiting Locations
NYU Langone Health
New York, New York 10016
New York, New York 10016
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health