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

NYU Langone Health

Status: Not yet enrolling

Conditions: Prosthetic-joint Infection

Treatments: Dietary Supplement: Culturelle Digestive Daily Probiotic Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06919913

24-01249

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

152 participants in 2 patient groups

Probiotic supplementation + Standard of care

Experimental group

Description:

Patients 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).

Treatment:

Dietary Supplement: Culturelle Digestive Daily Probiotic Capsule

Standard of care alone

No Intervention group

Description:

Patients do not receive any additional treatment and undergo SOC treatment.