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Gut Microbiome in Orthopaedics

NCT06371950 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-03-18

No results posted yet for this study

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

Conditions

  • Total Knee Arthroplasty
  • Inflammation
  • Gastrointestinal Health

Interventions

DIETARY_SUPPLEMENT

Probiotic Formula Bacillus subtilis

5 billion colony forming units (CFU) per day for 9 weeks (3 weeks before surgery to six weeks after surgery)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Brent Lanting, BESc, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2028-01-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT06371950 on ClinicalTrials.gov