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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT06636669
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Dysbiosis
  • Prosthetic-joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment- Probiotics and standard of care
    Participants randomized into this are will receive Culturelle probiotic and standard of care.
  • Active Comparator: Controls- Standard of care
    Participants randomized into this are will receive standard of care.

Primary Outcome Measure

Recurrent Prosthetic Joint Infection (PJI) [ Time Frame: 1 year, 2 years after PJI surgery ]

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Medical Center, Orthopedic SurgeryBostonMassachusetts02118-
New York University Langone OrthopedicsNew YorkNew York10016-

Find similar trials in Boston, MA

By research site
Boston Medical Center, Orthopedic Surgery· Boston, MANew York University Langone Orthopedics· New York, NY

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