RecruitingNot Applicable

The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee

United States152 participantsStarted 2025-07-12

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in erythrocyte sedimentation rate (ESR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Change in concentration of C-reactive protein (CRP)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Trial details

NCT IDNCT06919913

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Ran Schwarzkopf, MD

212-598-6000 ran.schwarzkopf@nyulangone.org

View on ClinicalTrials.gov More Prosthetic-joint Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in erythrocyte sedimentation rate (ESR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Change in concentration of C-reactive protein (CRP)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

Timeframe: Baseline, 6 weeks post-antibiotic therapy