Gut Microbiome in Orthopaedics

NCT06371950 | Withdrawn

• 1 other identifier: 123608
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Total Knee Arthroplasty; Inflammation; Gastrointestinal Health

Outcome Measures

Primary Outcomes (1)

• Implant Migration

  Tibial component migration over time calculated by measuring the position of the component compared to the bone using CT imaging.

  baseline, 6 weeks

Secondary Outcomes (2)

• Bone Density

  baseline, 6 weeks

• Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake

  6 weeks

Other Outcomes (32)

• Veterans Rand 12-Item Health Survey (VR-12)

  pre-operative, 6 weeks

• EuroQol-5D (EQ-5D)

  pre-operative, 6 weeks

• Western Ontario McMaster Osteoarthritis Index (WOMAC)

  pre-operative, 6 weeks

Study Arms (2)

Probiotic DE111®

EXPERIMENTAL

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.

Dietary Supplement: Probiotic Formula Bacillus subtilis

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotic Formula Bacillus subtilis DIETARY_SUPPLEMENT

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

Also known as: DE111®

Probiotic DE111®

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent Lanting, BESc, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 17, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)