Probiotics for Knee Replacement

(GUMBO Trial)

Overseen By Lyndsay Somerville, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Male, Inflammatory arthritis, Metabolic syndrome, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if probiotics can enhance recovery after knee replacement surgery by reducing joint pain and inflammation. Researchers are examining how probiotics might influence bone health and the gut microbiome, the collection of bacteria in the digestive system. Participants will take either a probiotic capsule (Probiotic Formula Bacillus subtilis) or a placebo (a pill with no active ingredient) before and after surgery. The study seeks postmenopausal women planning knee replacement surgery due to osteoarthritis. As an unphased trial, it offers a unique opportunity to contribute to scientific understanding and potentially improve recovery outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that probiotics, such as the Bacillus subtilis strain DE111®, are generally safe for daily use by adults. Studies suggest these probiotics may assist with bone and joint issues, including osteoporosis and osteoarthritis. The Bacillus subtilis DE111® strain has proven safe for long-term use. Although no direct evidence of harm exists, further research is needed to fully understand its effectiveness for joint problems. Currently, probiotics like DE111® appear to be well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for knee replacement focus on managing pain and inflammation with medications like NSAIDs or opioids. But the probiotic DE111® introduces a new approach by using Bacillus subtilis, a beneficial bacterium, to potentially enhance recovery. This probiotic is thought to support gut health, which may, in turn, influence inflammation and immune responses, offering a more natural and possibly safer alternative. Researchers are excited because this approach could reduce reliance on traditional pain medications and their associated side effects, promoting a healthier recovery process.

What evidence suggests that this probiotic treatment might be effective for knee replacement surgery?

This trial will compare the effects of the Probiotic Formula Bacillus subtilis, specifically DE111®, with a placebo in individuals undergoing knee replacement surgery. Research has shown that probiotics, like those in DE111®, might aid recovery after such surgeries. Studies have found that probiotics can reduce pain, improve movement, and lower swelling in knee osteoarthritis (joint inflammation). This suggests they might assist individuals undergoing joint surgeries by speeding up recovery and enhancing bone health. Probiotics support the gut, which can influence overall health, including bones and joints. While more research is needed, early results are promising for their use in joint health. ^{1 2 4 6 7}

Who Is on the Research Team?

Brent Lanting, BESc, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for post-menopausal women undergoing primary total knee replacement. It's exploring how a probiotic formula might influence their recovery, bone density, and gut health after surgery.

Inclusion Criteria

I am a woman aged 55-75 and have gone through menopause.

I am scheduled for a knee replacement due to arthritis.

Signed informed consent obtained prior to any study-related activities

Exclusion Criteria

Any contraindications for PET-MRI

Unable to understand and respond to the provided questionnaires

Metabolic syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Probiotic/Placebo Administration

Participants take a daily probiotic or placebo starting 3 weeks prior to surgery

3 weeks

Surgery and Immediate Post-operative Period

Participants undergo knee replacement surgery and immediate post-operative care

1 week

Post-surgery Probiotic/Placebo Administration

Participants continue taking a daily probiotic or placebo for 6 weeks after surgery

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Probiotic Formula Bacillus subtilis

Trial Overview The study tests Bacillus subtilis (a probiotic) against a placebo to see if it helps with implant stability, bone quality, and reduces inflammation after knee surgery. Participants won't know which treatment they're getting.

How Is the Trial Designed?

Group I: Probiotic DE111® Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10458220/

Probiotics in Orthopedics: From Preclinical Studies to Current ... Probiotics seem to be a promising supplementation for treatment of osteoporosis, osteoarthritis, muscle loss-related disease, wound and ulcer issues.

2. researchgate.net researchgate.net/publication/390667691_Clinical_efficacy_of_probiotic_supplementation_in_the_treatment_of_knee_osteoarthritis_a_meta-analysis

(PDF) Clinical efficacy of probiotic supplementation in the ... Oral probiotics had an ameliorative effect on function, pain, and inflammatory response in patients with KOA, but our results need to be validated in future ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020436/

Clinical efficacy of probiotic supplementation in the ... Oral probiotics had an ameliorative effect on function, pain, and inflammatory response in patients with KOA, but our results need to be validated in future ...

4. schulich.uwo.ca schulich.uwo.ca/about/news/2023/june/gut-biome-and-knee-replacement.html

New study investigates how probiotics can improve outcomes ... Researchers at Lawson Health Research Institute are examining whether the use of a daily probiotic can improve outcomes in patients who undergo total knee ...

5. oha.com oha.com/news/new-study-examining-if-probiotics-can-improve-outcomes-in-knee-replacement-surgeries

New Study Examining if Probiotics Can Improve Outcomes ... Researchers at Lawson Health Research Institute are examining whether the use of a daily probiotic can improve outcomes in patients who undergo a total knee ...

6. morningstar.com morningstar.com/news/accesswire/1093536msn/backbiome-reviews-safety-report-consumer-complaints-ingredients-breakdown-real-results-revealed-2025

BackBiome Reviews (SAFETY REPORT) Consumer ... ... safe for long-term daily use by adults of all ages. The probiotic strains used, particularly Bacillus subtilis DE111®, have undergone ...

7. mdpi.com mdpi.com/2075-4663/6/3/70

Effects of Probiotic (Bacillus subtilis DE111) ... Our data indicate that 12 weeks of probiotic supplementation provides no beneficial effect regarding body composition, physical performance, hormonal status, or ...