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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
152
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.
NYU Langone Health
New York, New York, United States
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline, 6 weeks post-antibiotic therapy
Change in concentration of C-reactive protein (CRP)
Time frame: Baseline, 6 weeks post-antibiotic therapy
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.
Time frame: Baseline, 6 weeks post-antibiotic therapy
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.
Time frame: Baseline, 6 weeks post-antibiotic therapy
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
KOOS-JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time frame: Baseline, 6 weeks post-antibiotic therapy
Number of participants with medical complications from prosthetic joint infection (PJI)
Outcome measure will be assessed using review of electronic medical record.
Time frame: 12 months post-surgery
Number of participants with surgical complications from PJI
Outcome measure will be assessed using review of electronic medical record.
Time frame: 12 months post-surgery
Mortality from PJI
Time frame: 12 months post-surgery
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.
Time frame: 12 months post-surgery
The Short Health Scale for GI symptoms (SHS-GI)
The SHS-GI is a 4-item questionnaire assessing the impact of gastrointestinal symptoms on quality of life, focusing on symptoms, social function, disease-related worry, and general well-being. Responses are graded on a 100-mm visual analog scale and maximum sum score for all items is 400, with higher values indicating worse outcome.
Time frame: 12 months post-surgery
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