Prosthetic-joint Infection
Conditions
Brief 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.
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erythrocyte sedimentation rate (ESR) | Baseline, 6 weeks post-antibiotic therapy | — |
| Change in concentration of C-reactive protein (CRP) | Baseline, 6 weeks post-antibiotic therapy | — |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health | Baseline, 6 weeks post-antibiotic therapy | 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) | Baseline, 6 weeks post-antibiotic therapy | 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. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) | Baseline, 6 weeks post-antibiotic therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with medical complications from prosthetic joint infection (PJI) | 12 months post-surgery | Outcome measure will be assessed using review of electronic medical record. |
| Number of participants with surgical complications from PJI | 12 months post-surgery | Outcome measure will be assessed using review of electronic medical record. |
| Mortality from PJI | 12 months post-surgery | — |
| Digestion-associated Quality of Life Questionnaire (DQLQ) | 12 months post-surgery | 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. |
| The Short Health Scale for GI symptoms (SHS-GI) | 12 months post-surgery | 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. |
Countries
United States
Contacts
CONTACTRan Schwarzkopf, MD
CONTACTDaniel Waren
PRINCIPAL_INVESTIGATORRan Schwarzkopf, MD
NYU Langone Health
Outcome results
None listed