Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee (NCT06636669) | Clinical Trial Compass
By InvitationPhase 4
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
United States152 participantsStarted 2025-08-15
Plain-language summary
Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection.
Despite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
All patients scheduled to undergo revision total knee arthroplasty (TKA) or total hip arthroplasty (THA) for infection at the participating institutions will be screened for eligibility in this prospective trial.
Inclusion Criteria:
* Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
* Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision 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.
* History of pancreatitis at any point in time.
* History of intolerance to probiotics.
* Immunocompromised patients.
* Revision TJA for aseptic reasons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrent Prosthetic Joint Infection (PJI)
Timeframe: 1 year, 2 years after PJI surgery
2
Surgical Site Infection (SSI)
Timeframe: 3 months, 6 months, 12 months post PJI surgery