Clinical trial NCT06919913: The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Official title: The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prosthetic-joint Infection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in erythrocyte sedimentation rate (ESR)
timeFrame: Baseline, 6 weeks post-antibiotic therapy
measure: Change in concentration of C-reactive protein (CRP)
timeFrame: Baseline, 6 weeks post-antibiotic therapy
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
timeFrame: Baseline, 6 weeks post-antibiotic therapy
measure: Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)
timeFrame: Baseline, 6 weeks post-antibiotic therapy
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
timeFrame: Baseline, 6 weeks post-antibiotic therapy
Secondary outcomes:
measure: Number of participants with medical complications from prosthetic joint infection (PJI)
timeFrame: 12 months post-surgery
measure: Number of participants with surgical complications from PJI
timeFrame: 12 months post-surgery
measure: Mortality from PJI
timeFrame: 12 months post-surgery
measure: Digestion-associated Quality of Life Questionnaire (DQLQ)
timeFrame: 12 months post-surgery
measure: The Short Health Scale for GI symptoms (SHS-GI)
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: