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Recruiting NCT06919913

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

No phase Interventional Prosthetic-joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturelle Digestive Daily Probiotic Capsule.
Who it may be relevant to
Registry conditions: Prosthetic-joint Infection. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Culturelle Digestive Daily Probiotic Capsule
    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.

Primary outcome measures

  • Change in erythrocyte sedimentation rate (ESR) [Time frame: Baseline, 6 weeks post-antibiotic therapy]
  • Change in concentration of C-reactive protein (CRP) [Time frame: Baseline, 6 weeks post-antibiotic therapy]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health [Time frame: Baseline, 6 weeks post-antibiotic therapy]
  • Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) [Time frame: Baseline, 6 weeks post-antibiotic therapy]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) [Time frame: Baseline, 6 weeks post-antibiotic therapy]
Secondary outcome measures (5)
  • Number of participants with medical complications from prosthetic joint infection (PJI) [Time frame: 12 months post-surgery]
  • Number of participants with surgical complications from PJI [Time frame: 12 months post-surgery]
  • Mortality from PJI [Time frame: 12 months post-surgery]
  • Digestion-associated Quality of Life Questionnaire (DQLQ) [Time frame: 12 months post-surgery]
  • The Short Health Scale for GI symptoms (SHS-GI) [Time frame: 12 months post-surgery]

Eligibility criteria

Inclusion criteria

  • Patients ages 18-90 years of age.
  • Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
  • Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision total joint arthroplasty (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.
  • Severe acute gastrointestinal diseases (active bowel leak, acute colitis, acute pancreatitis).
  • Active endocarditis.
  • History of pancreatitis
  • History of intolerance to probiotics.
  • Patients that are pregnant or lactating.
  • Immunocompromised patients and patients with immunosuppressive conditions (uncontrolled HIV, chemotherapy for cancer treatment, stem cell transplantation, immunosuppressive medications for solid organ transplant, systematic corticosteroid use, immunosuppressive medications for autoimmune dysfunction, and neonates).
  • Patients who are critically ill.
  • Revision TJA for aseptic reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06919913 · 24-01249

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗