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

March 2, 2026 updated by: NYU Langone Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
No Intervention: Standard of care alone
Patients do not receive any additional treatment and undergo SOC treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in erythrocyte sedimentation rate (ESR)
Time Frame: Baseline, 6 weeks post-antibiotic therapy
Baseline, 6 weeks post-antibiotic therapy
Change in concentration of C-reactive protein (CRP)
Time Frame: Baseline, 6 weeks post-antibiotic therapy
Baseline, 6 weeks post-antibiotic therapy
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.
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
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.
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
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.
Baseline, 6 weeks post-antibiotic therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-surgery
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.
12 months post-surgery
Mortality from PJI
Time Frame: 12 months post-surgery
12 months post-surgery
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.
12 months post-surgery
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.
12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Ran Schwarzkopf, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-01249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: ran.schwarzkopf@nyulangone.org The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will need to execute a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: ran.schwarzkopf@nyulangone.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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