Total Knee ArthroplastyGUMBONCT06371950
Gut Microbiome in Orthopaedics
A study testing Probiotic Formula Bacillus subtilis in people with Total Knee Arthroplasty and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Total Knee Arthroplasty, Inflammation, Gastrointestinal Health
- What is being tested?
- Probiotic Formula Bacillus subtilis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiome in Orthopaedics: Effect of Probiotics on Initial Implant Migration and Joint Inflammation After Total Knee Replacement
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
Read the 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.
- Being tested
- Probiotic Formula Bacillus subtilis, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula Bacillus subtilisDietary supplement
Also called DE111®
5 billion colony forming units (CFU) per day for 9 weeks (3 weeks before surgery to six weeks after surgery)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Migration
Tibial component migration over time calculated by measuring the position of the component compared to the bone using CT imaging.
Measured: baseline, 6 weeks
Secondary outcomes (2)
Bone Density
Volumetric bone mineral density over time measured in the anteromedial, anterolateral, posteromedial, and posterolateral regions surrounding the tibial component using CT imaging.
Measured: baseline, 6 weeks
Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake
Magnitude of standardized uptake values (SUV) of the [¹⁸F]FEPPA tracer uptake in the synovium as measured by PET-MRI. SUV will be calculated using the mean signal intensity, body weight, and decay-corrected injected dose.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: Unable to secure regulatory documentation for probiotic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brent Lanting, BESc, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371950
- Sponsor's protocol ID
- 123608
- Acronym
- GUMBO
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome in Orthopaedics: Effect of Probiotics on Initial Implant Migration and Joint Inflammation After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06371950
- Acronym / sponsor ID
- GUMBO / 123608
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure regulatory documentation for probiotic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic DE111® | Experimental | Dietary Supplement: Probiotic Formula Bacillus subtilis1 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. |
| Placebo | Placebo comparator | Other: Placebo1 capsule of placebo, to be taken once daily starting 3 weeks prior to surgery until 6 weeks after surgery. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Unable to understand and respond to the provided questionnaires
- Male sex
- Inflammatory arthritis
- Periprosthetic infection
- Prior surgery with hardware insertion in the target knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Formula Bacillus subtilisAlso: DE111®5 billion colony forming units (CFU) per day for 9 weeks (3 weeks before surgery to six weeks after surgery) | Dietary supplement | Probiotic DE111® |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Implant Migration
Time frame: baseline, 6 weeks
Tibial component migration over time calculated by measuring the position of the component compared to the bone using CT imaging.
2 secondary outcomes
Bone Density
Time frame: baseline, 6 weeks
Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Lanting, BESc, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Formula Bacillus subtilis in people with Total Knee Arthroplasty and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Migration (time frame: baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.