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Probiotics for Prosthetic Joint Infection

Phase 4
Waitlist Available
Led By Ayesha Abdeen, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of pancreatitis at any point in time
Immunocompromised patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years after pji surgery
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial aims to investigate the use of probiotics in reducing recurrent infections in patients treated for prosthetic joint infections (PJI). PJI is a serious complication following hip and knee joint replacements. Despite

Who is the study for?
This trial is for individuals who have had a hip or knee joint replacement and are dealing with an infection in that prosthetic joint. Participants should be undergoing standard treatment for this infection to qualify.
What is being tested?
The study is testing if taking probiotics along with the usual treatment can prevent infections from coming back after surgery for infected hip or knee replacements. Half of the patients will receive standard care, while the other half will also take probiotics.
What are the potential side effects?
Probiotics are generally considered safe but may cause digestive discomfort, like gas or bloating, especially when first starting them. They could also potentially lead to infections in very rare cases.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pancreatitis before.
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My immune system is weakened.
Select...
I have a fungal infection in my joint implant.
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I need a joint replacement revision not due to infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years after pji surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years after pji surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrent Prosthetic Joint Infection (PJI)
Surgical Site Infection (SSI)
Secondary study objectives
Complications related to the use of probiotics
Medical complications
Mortality
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment- Probiotics and standard of careExperimental Treatment2 Interventions
Participants randomized into this are will receive Culturelle probiotic and standard of care.
Group II: Controls- Standard of careActive Control1 Intervention
Participants randomized into this are will receive standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

American Association of Hip and Knee SurgeonsUNKNOWN
3 Previous Clinical Trials
2,170 Total Patients Enrolled
Boston Medical CenterLead Sponsor
402 Previous Clinical Trials
883,743 Total Patients Enrolled
Ayesha Abdeen, MDPrincipal InvestigatorBoston Medical Center
~101 spots leftby Dec 2025
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