RecruitingNot ApplicableNCT06919913

The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee

Sponsor

NYU Langone Health

Enrollment

152 participants

Start Date

Jul 12, 2025

Study Type

INTERVENTIONAL

Conditions

Prosthetic joint infection

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 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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

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 Criteria10

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.

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Interventions

DIETARY_SUPPLEMENTCulturelle Digestive Daily Probiotic Capsule

Each capsule contains 10 billion colony-forming units (CFU) of Lactobacillus rhamnosus GG. Subjects will self-administer 1 oral capsule daily for 6 weeks post operatively.