Gut Microbiome in Orthopaedics

NCT ID: NCT06371950

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-01-01

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

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.

Conditions

Total Knee Arthroplasty; Inflammation; Gastrointestinal Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic DE111®

1 capsule of probiotic DE111® containing 5 billion CFU Bacillus subtilis, to be taken once daily starting 3 weeks prior to surgery until 6 weeks after surgery.

Group Type: EXPERIMENTAL

Probiotic Formula Bacillus subtilis

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

1 capsule of placebo, to be taken once daily starting 3 weeks prior to surgery until 6 weeks after surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Probiotic Formula Bacillus subtilis

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

DE111®

Eligibility Criteria

Inclusion Criteria

• Signed informed consent obtained prior to any study-related activities
• Postmenopausal female patients of London Health Sciences Centre (LHSC) aged 55-75 years
• Scheduled to undergo primary total knee replacement for osteoarthritis

Exclusion Criteria

• Unable to understand and respond to the provided questionnaires
• Male sex
• Inflammatory arthritis
• Periprosthetic infection
• Prior surgery with hardware insertion in the target knee
• Metabolic syndrome
• Inflammatory bowel disease
• Body mass index <18.5 kg/m2
• Immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
• Any contraindications for PET-MRI
• Allergy to cephalosporin antibiotics

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Brent Lanting

Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent Lanting, BESc, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

123608

Identifier Type: -

Identifier Source: org_study_id