The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
1 other identifier
interventional
152
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
July 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 4, 2026
March 1, 2026
1.5 years
March 27, 2025
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (5)
Number of participants with medical complications from prosthetic joint infection (PJI)
12 months post-surgery
Number of participants with surgical complications from PJI
12 months post-surgery
Mortality from PJI
12 months post-surgery
Digestion-associated Quality of Life Questionnaire (DQLQ)
12 months post-surgery
The Short Health Scale for GI symptoms (SHS-GI)
12 months post-surgery
Study Arms (2)
Probiotic supplementation + Standard of care
EXPERIMENTALPatients 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 INTERVENTIONPatients do not receive any additional treatment and undergo SOC treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ran Schwarzkopf, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 9, 2025
Study Start
July 12, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- 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
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.