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.
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.
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.
Parallel
Culturelle Digestive Daily Probiotic Capsule
Dietary supplementEach 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.
Change in erythrocyte sedimentation rate (ESR)
Change in concentration of C-reactive protein (CRP)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
The PROMIS Global Health measure consists of 10 items designed to assess an individual's overall health status, encompassing physical, mental, and social well-being. Each item is scored on a Likert scale of 1-5. Scores are reported on a T-score metric, with a mean of 50 and a standard deviation of 10, meaning a score of 50 represents the average for the reference population. Higher scores indicate better health.
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)
HOOS-JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.
Number of participants with medical complications from prosthetic joint infection (PJI)
Outcome measure will be assessed using review of electronic medical record.
Number of participants with surgical complications from PJI
Outcome measure will be assessed using review of electronic medical record.
Mortality from PJI
Digestion-associated Quality of Life Questionnaire (DQLQ)
The DQLQ is a 9-items questionnaire assessing how digestive events and experiences affect mental well-being and physical ability. Participants respond based on how digestive events over the past seven days affected their quality of life using a 7-point frequency Likert scale (0 = never to 1 = always). Scores can range from 0 to 9; higher scores indicate a poorer digestion-associated quality of life.
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