Recruiting

Probiotics with SOC

Sponsor:

NYU Langone Health

Code:

NCT06919913

Conditions

Prosthetic-joint Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Culturelle Digestive Daily Probiotic Capsule

Study Details

Brief summary:

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.

Conditions

Prosthetic-joint Infection

Study ID

NCT06919913

Start date

Jul 12, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ran Schwarzkopf, MD

212-598-6000ran.schwarzkopf@nyulangone.org

Daniel Waren

212-598-6245daniel.waren@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-04.