Probiotics for Prosthetic Joint Infection

Overseen By Ran Schwarzkopf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Immunosuppressive medications

Disqualifiers: Fungal PJI, Inflammatory bowel disease, Immunocompromised, Critically ill, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

152 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It mentions that there is an anticipated plan for eventual discontinuation of oral/IV antibiotics, but it doesn't provide details about other medications.

What data supports the effectiveness of the treatment Culturelle Digestive Daily Probiotic Capsule for prosthetic joint infection?

Research shows that probiotics can help reduce inflammation in conditions like rheumatoid arthritis, which is an inflammatory disease. This suggests that probiotics might also help manage inflammation in prosthetic joint infections, although direct evidence for this specific condition is not available. ^{1 2 3 4 5}

Are probiotics generally safe for human consumption?

Probiotics, like Lactobacilli and bifidobacteria, are generally considered safe for human consumption, with millions of people using them daily without increased risk. While rare cases of infections have been reported, studies show that probiotics are well-tolerated, even in immune-compromised individuals, and serious adverse events are not typically linked to their use. ^{6 7 8 9 10}

How do probiotics differ from other treatments for prosthetic joint infection?

Probiotics are unique because they use beneficial bacteria to potentially help manage infections, unlike traditional treatments that rely on antibiotics and surgery. This approach may offer a novel way to support the body's natural defenses against infection without the side effects associated with long-term antibiotic use. ^{11 12 13 14 15}

Research Team

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals with prosthetic joint infections in the hip or knee. Participants should have undergone standard treatment for these infections and are now looking at additional options to improve their immune response and overall outcomes.

Inclusion Criteria

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

I am scheduled for surgery to treat an infection in my joint replacement, with plans to stop antibiotics later.

Exclusion Criteria

I have a fungal infection in my joint implant.

I have an ongoing heart infection.

Patients who are critically ill

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive probiotics in addition to standard of care for 6 weeks during post-operative antibiotic treatment

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

12 months

Treatment Details

Interventions

• Culturelle Digestive Daily Probiotic Capsule

Trial Overview The study tests if taking Culturelle Digestive Daily Probiotic Capsules, along with regular treatment, can better immunological markers in patients who've had surgery due to infected hip or knee prosthetics. It also looks at whether this leads to fewer medical issues and better gastrointestinal health as reported by patients.

Participant Groups

Group I: Probiotic supplementation + Standard of care Experimental Treatment 1 Intervention

Patients will receive their first dose of the probiotic within 48 hours of starting post-operative antibiotic treatment. The probiotic is continued for the initial 6 weeks of antibiotic treatment in addition to standard of care (SOC).

Group II: Standard of care alone Active Control 1 Intervention

Patients do not receive any additional treatment and undergo SOC treatment.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

In a three-month study involving 29 patients with rheumatoid arthritis, probiotics did not show a statistically significant improvement in the ACR20 response compared to placebo, indicating limited efficacy as an adjunctive therapy.

However, the probiotic group did experience a significant improvement in their Health Assessment Questionnaire (HAQ) scores, suggesting some functional benefits despite the lack of overall clinical improvement in RA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis. Pineda, Mde L., Thompson, SF., Summers, K., et al.[2022]

In a clinical trial involving 46 patients with rheumatoid arthritis, supplementation with Lactobacillus casei 01 for 8 weeks significantly reduced disease activity and inflammatory cytokines compared to a placebo group.

The probiotic treatment led to a decrease in proinflammatory cytokines like tumor necrosis factor-α and interleukin-6, while increasing the regulatory cytokine interleukin-10, suggesting a beneficial effect on inflammation in RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. Vaghef-Mehrabany, E., Alipour, B., Homayouni-Rad, A., et al.[2022]

Probiotics, including Lactobacilli and bifidobacteria, are generally considered safe for human consumption, with rare cases of serious infections like bacteremia reported but no significant increase in risk observed in the general population.

Controlled clinical trials have shown that probiotics can be used safely, and it is recommended that their use in trials be monitored by a data-safety board to ensure participant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of probiotics. Snydman, DR.[2022]

A systematic review of 57 clinical studies found that probiotics and synbiotics are safe for immune-compromised adults, with no serious adverse events linked to these products, indicating they are well tolerated.

Probiotics and synbiotics resulted in fewer adverse events compared to control groups, but the study highlighted issues with inconsistent reporting of adverse events, suggesting a need for standardized reporting to enhance data reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

References

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

A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Probiotic therapy for the treatment of spondyloarthritis: a randomized controlled trial. [2015]

3. 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]

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

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

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

Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Compositional Quality and Potential Gastrointestinal Behavior of Probiotic Products Commercialized in Italy. [2023]

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

The safety of probiotics. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Microbiological evaluation of commercial probiotic products available in Italy. [2009]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? [2014]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of probiotics]. [2020]

11. Brazil pubmed.ncbi.nlm.nih.gov

UPDATE ON INFECTIONS IN ARTICULAR PROSTHESIS. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Prosthetic knee septic arthritis due to Pseudomonas stutzeri. [2020]

13. Italy pubmed.ncbi.nlm.nih.gov

Epidemiological and clinical features of prosthetic joint infections caused by gram-negative bacteria. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Management of infections of osteoarticular prosthesis. [2015]

15. England pubmed.ncbi.nlm.nih.gov

Microbiological diagnosis of prosthetic joint infections: a prospective evaluation of four bacterial culture media in the routine laboratory. [2019]