Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-27 @ 7:23 PM
Study NCT ID:
NCT06371950
Status:
WITHDRAWN
Last Update Posted:
2025-03-18
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiome in Orthopaedics
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Gut Microbiome in Orthopaedics: Effect of Probiotics on Initial Implant Migration and Joint Inflammation After Total Knee Replacement
Status:
WITHDRAWN
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to secure regulatory documentation for probiotic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUMBO
Brief 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
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
Detailed 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: