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New treatment option for Prosthetic-joint Infection
Official title The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
ClinicalTrials.gov ID: NCT06919913
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- Patients who are critically ill.
- Revision TJA for aseptic reasons.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.