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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNYU Langone Health

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Culturelle Digestive Daily Probiotic Capsule

Treatment groups

152 Participants
are divided into 2 treatment groups

Sponsors and collaborators