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

NCT ID: NCT06636669

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-06-30

Brief 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.

Detailed Description

The primary and secondary aims for this RCT are:

Primary Aim 1.1 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates (deep infection) within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).

Secondary Aims 2.1 To evaluate the incidence of superficial infections including wound drainage, cellulitis, or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).

2.2 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI.

2.3 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).

2.4 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).

2.5 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).

2.6 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms (probiotics and standard of care). The risk of developing C. difficile infection is present for 90 days following cessation of antibiotic treatment.

Conditions

Prosthetic-joint Infection; Dysbiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment- Probiotics and standard of care

Participants randomized into this are will receive Culturelle probiotic and standard of care.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DRUG

Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.

Standard of care

Intervention Type: OTHER

Standard of care (SOC) treatment includes surgery and antimicrobials.

Controls- Standard of care

Participants randomized into this are will receive standard of care.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care (SOC) treatment includes surgery and antimicrobials.

Interventions

Probiotic

Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.

Intervention Type: DRUG

Standard of care

Standard of care (SOC) treatment includes surgery and antimicrobials.

Intervention Type: OTHER

Other Intervention Names

Culturelle

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Association of Hip and Knee Surgeons

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayesha Abdeen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center, Orthopedic Surgery

Boston, Massachusetts, United States

New York University Langone Orthopedics

New York, New York, United States

Countries

United States

Other Identifiers

H-44452

Identifier Type: -

Identifier Source: org_study_id