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

NCT06636669 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: H-44452
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Prosthetic-joint Infection; Dysbiosis

Keywords

Probiotics; Hip total joint arthroplasty (TJA); Knee TJA; Recurrent reinfection; DAIR; Surgical site infection (SSI); Patient Reported Outcome Measures (PROMs)

Outcome Measures

Primary Outcomes (2)

• Recurrent Prosthetic Joint Infection (PJI)

  The number of participants who develop PJI after PJI surgery will be abstracted from electronic medical records.

  1 year, 2 years after PJI surgery

• Surgical Site Infection (SSI)

  The number of participants who develop SSI within 12 months of PJI surgery will be abstracted from electronic medical records.

  3 months, 6 months, 12 months post PJI surgery

Secondary Outcomes (10)

• Medical complications

  3 months, 6 months, 12 months post PJI surgery

• Surgical complications

  3 months, 6 months, 12 months post PJI surgery

• Sepsis

  3 months, 6 months, 12 months post PJI surgery

• Re-operation for recurrent infection

  3 months, 6 months, 12 months post PJI surgery

• Revision surgery

  3 months, 6 months, 12 months post PJI surgery

Study Arms (2)

Treatment- Probiotics and standard of care

EXPERIMENTAL

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

Drug: Probiotic; Other: Standard of care

Controls- Standard of care

ACTIVE COMPARATOR

Participants randomized into this are will receive standard of care.

Other: Standard of care

Interventions

Probiotic DRUG

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

Also known as: Culturelle

Treatment- Probiotics and standard of care

Standard of care OTHER

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

Controls- Standard of care; Treatment- Probiotics and standard of care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• American Association of Hip and Knee Surgeons: collaborator

Study Sites (2)

Boston Medical Center, Orthopedic Surgery

Boston, Massachusetts, 02118, United States

Location

New York University Langone Orthopedics

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dysbiosis; Reinfection; Surgical Wound Infection

Interventions

Probiotics; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Recurrence; Disease Attributes; Wound Infection; Infections; Postoperative Complications

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ayesha Abdeen, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-centered, randomized controlled trial (RCT) with two arms will be conducted at two academic, tertiary care centers.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)