Probiotics for Prosthetic Joint Infection

Recruiting at 1 trial location

Overseen By Ayesha Abdeen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Medical Center

Must be taking: Antibiotics

Disqualifiers: Fungal PJI, Immunocompromised, Gut issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

152 Participants Needed

Trial Summary

What is the purpose of this trial?

Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection. Despite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that patients will continue with standard care, which includes antibiotics, alongside the probiotic treatment.

What data supports the effectiveness of the treatment Probiotic, Beneficial bacteria, Live cultures, Microbial supplements for Prosthetic Joint Infection?

Probiotics have shown potential in improving immune function and preventing infections in various clinical settings, such as severe trauma and inflammatory arthritis, which suggests they might help in managing infections related to prosthetic joints. ^{1 2 3 4 5}

Are probiotics safe for use in humans?

Probiotics are generally considered safe for most people, but there have been rare reports of serious infections like bacteremia (bacteria in the blood) and fungemia (fungus in the blood), especially in people with weakened immune systems or chronic illnesses. ^{6 7 8 9 10}

How does the probiotic treatment for prosthetic joint infection differ from other treatments?

This probiotic treatment is unique because it uses live microorganisms to potentially modulate the immune system and reduce inflammation, which is different from traditional antibiotic treatments. Probiotics like Lactobacillus casei have shown promise in reducing inflammation and osteolysis (bone loss) in other conditions, suggesting a novel approach to managing prosthetic joint infections by altering gut microbiota and immune responses. ^{3 9 11 12 13}

Research Team

Ayesha Abdeen, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Patients with prior PJI in the same joint that has recurred

Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent

Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria

Exclusion Criteria

History of intolerance to probiotics

My immune system is weakened.

I have had pancreatitis before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment and probiotics for 6 weeks after the index surgical treatment for PJI

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and recurrent infection after treatment

12 months

Regular follow-up visits at 3, 6, and 12 months post-surgery

Treatment Details

Interventions

• Probiotic

Trial Overview 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.

Participant Groups

Group I: Treatment- Probiotics and standard of care Experimental Treatment 2 Interventions

Participants randomized into this are will receive Culturelle probiotic and standard of care.

Group II: Controls- Standard of care Active Control 1 Intervention

Participants randomized into this are will receive standard of care.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

Findings from Research

Probiotic bacteria can provide health benefits when consumed in adequate amounts, and their effects vary based on specific strains, which can lead to different health claims.

An international expert group has identified key areas for probiotic application, including metabolism, intestinal disorders, infections, and allergies, and emphasized the need for standardized guidelines to assess their efficacy and characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for substantiating the evidence for beneficial effects of probiotics: current status and recommendations for future research. Rijkers, GT., Bengmark, S., Enck, P., et al.[2023]

Probiotics, which are live microorganisms that can positively alter gut microflora, have been shown to be effective in treating and preventing various gastrointestinal and non-gastrointestinal diseases, including respiratory infections and hypercholesterolemia.

Probiotic supplements are generally considered safe, as they contain microorganisms similar to those naturally found in the human body, highlighting their potential for beneficial health effects when consumed appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics in clinical practice: an overview. Zuccotti, GV., Meneghin, F., Raimondi, C., et al.[2019]

Probiotics have the potential to improve gut health in critically ill patients by reducing harmful pathogens and supporting immune function, but current strains and doses may not provide immediate benefits and require long-term use for effectiveness.

There is still a lack of conclusive evidence regarding the safety and optimal use of probiotics in critically ill patients, particularly concerning their risk of causing infections, which means they cannot be routinely recommended at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic use in the critically ill. Singhi, SC., Baranwal, A.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of probiotic supplementation in 8 types of inflammatory arthritis: A systematic review and meta-analysis of 34 randomized controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of probiotic administration in inflammatory arthritis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Guidance for substantiating the evidence for beneficial effects of probiotics: current status and recommendations for future research. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Probiotics for severe trauma patients. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Probiotics in clinical practice: an overview. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of probiotic supplementation on mortality of induced 1,2-dimethylhydrazine carcinogenesis in a mouse model. [2012]

7. India pubmed.ncbi.nlm.nih.gov

Probiotic use in the critically ill. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of probiotics]. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Probiotics and the immune response to vaccines. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Controversies in the management of the critically ill: the role of probiotics. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Probiotics. [2009]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Probiotics, immune function, infection and inflammation: a review of the evidence from studies conducted in humans. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Probiotics protect mice from CoCrMo particles-induced osteolysis. [2022]