Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic supplementation + Standard of care | Experimental | Patients will receive their first dose of the probiotic within 48 hours of starting post-operative antibiotic treatment. The probiotic is continued for the initial 6 weeks of antibiotic treatment in addition to standard of care (SOC). |
|
| Standard of care alone | No Intervention | Patients do not receive any additional treatment and undergo SOC treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturelle Digestive Daily Probiotic Capsule | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | Baseline, 6 weeks post-antibiotic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with medical complications from prosthetic joint infection (PJI) | Outcome measure will be assessed using review of electronic medical record. | 12 months post-surgery |
| Number of participants with surgical complications from PJI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Schwarzkopf, MD | Contact | 212-598-6000 | ran.schwarzkopf@nyulangone.org | |
| Daniel Waren | Contact | 212-598-6245 | daniel.waren@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Ran Schwarzkopf, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: ran.schwarzkopf@nyulangone.org The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will need to execute a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: ran.schwarzkopf@nyulangone.org
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Outcome measure will be assessed using review of electronic medical record.
| 12 months post-surgery |
| Mortality from PJI | 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. | 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. | 12 months post-surgery |