Probiotics for Knee Replacement (GUMBO Trial)

N/A

Waitlist Available

Led By Brent Lanting, BESc, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative, 6 weeks

Summary

"This trial aims to study the effects of probiotics on post-menopausal women undergoing knee replacement surgery. The study will compare probiotic use with a placebo to see if probiotics can improve bone quality

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Probiotics are generally considered safe but may cause digestive upset like gas or bloating in some people. The specific side effects of Bacillus subtilis will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Implant Migration

Secondary study objectives

Bone Density

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

Other study objectives

Diet and Supplement Questionnaire

EuroQol-5D (EQ-5D)

Histopathology

+29 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Probiotic DE111®Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out