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

NCT06919913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-03-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Ran Schwarzkopf, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-12
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06919913 on ClinicalTrials.gov