protocolSection identificationModule nctId: NCT06371950, orgStudyIdInfo id: 123608, briefTitle: Gut Microbiome in Orthopaedics, acronym: GUMBO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Total Knee Arthroplasty, conditions: Inflammation, conditions: Gastrointestinal Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic Formula Bacillus subtilis, interventions name: Placebo, outcomesModule primaryOutcomes measure: Implant Migration, secondaryOutcomes measure: Bone Density, secondaryOutcomes measure: Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake, otherOutcomes measure: Veterans Rand 12-Item Health Survey (VR-12), otherOutcomes measure: EuroQol-5D (EQ-5D), otherOutcomes measure: Western Ontario McMaster Osteoarthritis Index (WOMAC), otherOutcomes measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP), otherOutcomes measure: Patient Global Assessment (PGA), otherOutcomes measure: University of California, Los Angeles (UCLA) Activity Score, otherOutcomes measure: Oxford Knee Score - English for Canada, otherOutcomes measure: Knee Society Score (KSS), otherOutcomes measure: Presence of MRSA, otherOutcomes measure: Microbial Diversity - Taxonomic Differences, otherOutcomes measure: Microbial Diversity - Taxonomic Correlation, otherOutcomes measure: Diet and Supplement Questionnaire, otherOutcomes measure: Histopathology, otherOutcomes measure: Immunohistochemistry, otherOutcomes measure: Inflammatory Blood Marker: C-Reactive Protein, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-1B, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-6, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-8, otherOutcomes measure: Inflammatory Blood Marker: Tumor Necrosis Factor Alpha, otherOutcomes measure: Inflammatory Blood Marker: Erythrocyte Sedimentation Rate, otherOutcomes measure: Inflammatory Blood Marker: Alkaline Phosphatase, otherOutcomes measure: Inflammatory Blood Marker: Calcium, otherOutcomes measure: Inflammatory Blood Marker: Albumin, otherOutcomes measure: Inflammatory Blood Marker: Urate, otherOutcomes measure: Inflammatory Blood Marker: Total Protein, otherOutcomes measure: Inflammatory Blood Marker: Creatinine, otherOutcomes measure: Inflammatory Blood Marker: Vitamin D, otherOutcomes measure: Inflammatory Blood Marker: White Blood Cell Count, otherOutcomes measure: Inflammatory Blood Marker: Red Blood Cell Count, otherOutcomes measure: Inflammatory Blood Marker: Hemoglobin Concentration, otherOutcomes measure: Inflammatory Blood Marker: Hematocrit Percentage, otherOutcomes measure: Inflammatory Blood Marker: Platelet Count, eligibilityModule sex: FEMALE, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre, city: London, state: Ontario, zip: N6A 5A5, country: Canada, contacts name: Rachel Vander Deen, role: CONTACT, phone: 519-685-8500, phoneExt: 34269, email: Rachel.VanderDeen@lhsc.on.ca, contacts name: Lyndsay Somerville, PhD, role: CONTACT, phone: 519-685-8500, phoneExt: 36645, email: Lyndsay.Somerville@lhsc.on.ca, contacts name: Brent Lanting, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jeremy Burton, PhD, role: SUB_INVESTIGATOR, contacts name: Tom Appleton, PhD, role: SUB_INVESTIGATOR, contacts name: Matthew Teeter, PhD, role: SUB_INVESTIGATOR, contacts name: Jonath Thiessen, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False