Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Probiotic supplementation + Standard of care 		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).
  • Dietary Supplement: Culturelle Digestive Daily Probiotic Capsule
    Each capsule contains 10 billion colony-forming units (CFU) of Lactobacillus rhamnosus GG. Subjects will self-administer 1 oral capsule daily for 6 weeks post operatively.
No Intervention
Standard of care alone 		Patients do not receive any additional treatment and undergo SOC treatment.

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Ran Schwarzkopf, MD
212-598-6000
ran.schwarzkopf@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.