Probiotics for Knee Replacement
(GUMBO Trial)
Trial Summary
What is the purpose of this trial?
Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:* to compare implant migration between groups from baseline to six weeks post-surgery* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery
Research Team
Brent Lanting, BESc, MD
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Eligibility Criteria
This trial is for post-menopausal women undergoing primary total knee replacement. It's exploring how a probiotic formula might influence their recovery, bone density, and gut health after surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Probiotic/Placebo Administration
Participants take a daily probiotic or placebo starting 3 weeks prior to surgery
Surgery and Immediate Post-operative Period
Participants undergo knee replacement surgery and immediate post-operative care
Post-surgery Probiotic/Placebo Administration
Participants continue taking a daily probiotic or placebo for 6 weeks after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Probiotic Formula Bacillus subtilis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lawson Health Research Institute
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor