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Search / Trial NCT06636669

Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee

Launched by BOSTON MEDICAL CENTER · Oct 8, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Probiotics Hip Total Joint Arthroplasty (Tja) Knee Tja Recurrent Reinfection Dair Surgical Site Infection (Ssi) Patient Reported Outcome Measures (Pro Ms)

ClinConnect Summary

This clinical trial is studying whether taking probiotics can help prevent repeated infections in patients who have had surgery to replace a hip or knee joint due to an infection. After surgery, patients typically receive antibiotics to fight the infection, but some still experience re-infection. The researchers believe that probiotics, which are good bacteria that can help improve gut health, might support the immune system and reduce the chances of needing more surgery due to re-infection.

To be eligible for this study, patients must be scheduled for surgery to treat a joint infection and have a diagnosis based on specific criteria. They should also have had a previous infection in the same joint that came back. Participants will be divided into two groups: one will receive standard treatment plus probiotics, while the other will just receive standard treatment. The main goal is to see if the group taking probiotics has fewer re-infections within a year. This trial is important because it could lead to better prevention strategies for joint infections, which can have serious consequences.

Gender

ALL

Eligibility criteria

  • 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

About Boston Medical Center

Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.

Locations

Boston, Massachusetts, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Ayesha Abdeen, MD

Principal Investigator

Boston Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported