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Probiotic

Probiotic DE111® for Total 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 intraoperative

Awards & highlights

GUMBO Trial 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.Check my eligibility

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.See study design

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.

GUMBO 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Implant Migration

Secondary outcome measures

Bone Density

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

Other outcome measures

Diet and Supplement Questionnaire

EuroQol-5D (EQ-5D)

Histopathology

+29 more

GUMBO 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

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,702 Total Patients Enrolled

Brent Lanting, BESc, MDPrincipal InvestigatorLawson Health Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Information from clinicaltrials.gov shows that this particular trial is no longer accepting new participants. It was initially listed on the website on May 1, 2024, and the most recent update was made on April 12, 2024. Despite this trial being closed for recruitment, it's worth noting that there are currently 376 other trials actively seeking patients."

Answered by AI

Could individuals younger than 65 years of age participate in this research trial?

"This research is enrolling individuals aged over 55 years but under 75 years."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for involvement in this medical study?

"Candidates eligible for participation in this trial must have undergone total knee replacement surgery and be aged between 55 to 75 years. The study aims to enroll a cohort of 30 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gut Microbiome in Orthopaedics

Brent Lanting 2024. "Gut Microbiome in Orthopaedics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06371950.

All > Knee Replacement