About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Culturelle Digestive Daily Probiotic Capsule