The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06919913
Status
Recruiting
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Conditions

  • Prosthetic-joint Infection

Eligibility Criteria

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

Interventions

  • Culturelle Digestive Daily Probiotic Capsule — DIETARY_SUPPLEMENT
    Each capsule contains 10 billion colony-forming units (CFU) of Lactobacillus rhamnosus GG. Subjects will self-administer 1 oral capsule daily for 6 weeks post operatively.

Study Details

The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.

Key Dates

Start date
Jul 12, 2025
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

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

Arms

  • Experimental: Probiotic supplementation + Standard of care
    Patients will receive their first dose of the probiotic within 48 hours of starting post-operative antibiotic treatment. The probiotic is continued for the initial 6 weeks of antibiotic treatment in addition to standard of care (SOC).
  • No Intervention: Standard of care alone
    Patients do not receive any additional treatment and undergo SOC treatment.

Primary Outcome Measure

Change in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline, 6 weeks post-antibiotic therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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