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NCT Number: NCT06919913

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

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.

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Key information

Conditions

Prosthetic-joint Infection

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in erythrocyte sedimentation rate (ESR)

    Time frame: Baseline, 6 weeks post-antibiotic therapy

  2. Change in concentration of C-reactive protein (CRP)

    Time frame: Baseline, 6 weeks post-antibiotic therapy

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health

    Time frame: Baseline, 6 weeks post-antibiotic therapy

    The PROMIS Global Health measure consists of 10 items designed to assess an individual's overall health status, encompassing physical, mental, and social well-being. Each item is scored on a Likert scale of 1-5. Scores are reported on a T-score metric, with a mean of 50 and a standard deviation of 10, meaning a score of 50 represents the average for the reference population. Higher scores indicate better health.

  4. Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)

    Time frame: Baseline, 6 weeks post-antibiotic therapy

    HOOS-JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.

  5. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

    Time frame: Baseline, 6 weeks post-antibiotic therapy

    KOOS-JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

Secondary outcomes

  1. Number of participants with medical complications from prosthetic joint infection (PJI)

    Time frame: 12 months post-surgery

    Outcome measure will be assessed using review of electronic medical record.

  2. Number of participants with surgical complications from PJI

    Time frame: 12 months post-surgery

    Outcome measure will be assessed using review of electronic medical record.

  3. Mortality from PJI

    Time frame: 12 months post-surgery

  4. Digestion-associated Quality of Life Questionnaire (DQLQ)

    Time frame: 12 months post-surgery

    The DQLQ is a 9-items questionnaire assessing how digestive events and experiences affect mental well-being and physical ability. Participants respond based on how digestive events over the past seven days affected their quality of life using a 7-point frequency Likert scale (0 = never to 1 = always). Scores can range from 0 to 9; higher scores indicate a poorer digestion-associated quality of life.

  5. The Short Health Scale for GI symptoms (SHS-GI)

    Time frame: 12 months post-surgery

    The SHS-GI is a 4-item questionnaire assessing the impact of gastrointestinal symptoms on quality of life, focusing on symptoms, social function, disease-related worry, and general well-being. Responses are graded on a 100-mm visual analog scale and maximum sum score for all items is 400, with higher values indicating worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Waren

CONTACT

[email protected]

212-598-6245

Ran Schwarzkopf, MD

CONTACT

[email protected]

212-598-6000

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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