Peri-operative probiotics to support immune recovery after hip or knee prosthetic joint infection
The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
This test adds a daily probiotic to usual surgery and antibiotics to see if it lowers immune markers and improves gut symptoms in adults treated for hip or knee prosthetic joint infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06919913 on ClinicalTrials.gov |
What this trial studies
This interventional study gives adults diagnosed with prosthetic joint infection a daily over-the-counter probiotic (Culturelle Digestive Daily) in addition to standard surgical and antibiotic care. Eligible participants are ages 18–90 with PJI by MSIS criteria who are planned for DAIR or single- or two-stage revision with an anticipated discontinuation of antibiotics. Outcomes include changes in immunological markers, medical and surgical complications, mortality, and gastrointestinal-specific patient-reported outcome measures. The protocol excludes fungal PJI, significant or acute gastrointestinal disease, pregnancy or lactation, immunocompromise, and known probiotic intolerance, and is conducted at NYU Langone Health in New York City.
Who should consider this trial
Good fit: Adults aged 18–90 with hip or knee prosthetic joint infection diagnosed by MSIS criteria who are planned for DAIR or revision surgery with an anticipated stop to antibiotics and who do not have major gut disease or immunocompromise.
Not a fit: Patients with fungal PJI, active severe gastrointestinal disease or prior intestinal surgery that compromises gut integrity, pregnancy or lactation, immunocompromise, or known probiotic intolerance are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding probiotics could lower inflammatory markers, reduce complications, and improve gastrointestinal symptoms after PJI treatment.
How similar studies have performed: Some smaller studies in other surgical and medical settings show probiotics can change inflammatory markers and improve GI symptoms, but using probiotics specifically during PJI treatment is novel and not well established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ran Schwarzkopf, MD — NYU Langone Health
- Study coordinator: Ran Schwarzkopf, MD
- Email: ran.schwarzkopf@nyulangone.org
- Phone: 212-598-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.