Gut Microbiome in Orthopaedics

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

Participants will take a daily probiotic (DE111®) or placebo once daily starting 3 weeks prior to surgery until six weeks after surgery. The following will be completed at baseline and 6 weeks: - Bloodwork - Fecal sample collection - MRSA swab - Patient-reported outcome measures - CT imaging scan In addition, the following will be done: - Intraoperative fluid and tissue collection - Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) scan at 6 weeks post-surgery Researchers will compare the probiotic and placebo groups for any significant differences in implant stability, bone quality, inflammation, gut microbiome composition, and pain. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06371950
Study type	Interventional
Source	Lawson Health Research Institute
Contact	Rachel Vander Deen
Phone	519-685-8500
Email	Rachel.VanderDeen@lhsc.on.ca
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2024
Completion date	January 1, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gut Microbiome in Orthopaedics — GUMBO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms