Peri-operative probiotics to support immune recovery after hip or knee prosthetic joint infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.