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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking probiotics alongside standard medical care can improve recovery from prosthetic joint infections (PJI). Specifically, it examines if probiotics can reduce inflammation markers, lower complications, and enhance digestive health in individuals with PJI. Participants will receive either standard care alone or standard care with a probiotic supplement (Culturelle Digestive Daily Probiotic Capsule). This trial suits those diagnosed with a prosthetic joint infection and undergoing surgical and antibiotic treatment. As an unphased trial, it provides an opportunity to contribute to understanding the potential benefits of probiotics in enhancing recovery from 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that probiotics, such as the Culturelle Digestive Daily Probiotic Capsule, are generally safe. Studies have found that probiotics and synbiotics (a combination of probiotics and prebiotics) usually cause fewer side effects than not using them. Some people might experience mild digestive issues, such as gas and bloating.

This probiotic contains Lactobacillus rhamnosus GG, one of the most researched probiotics, known to help reduce digestive problems like diarrhea. Probiotics have also been safely used in other situations, such as preventing infections after abdominal surgery. Overall, probiotics are well-tolerated by most people and have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for prosthetic joint infections, which typically involves antibiotics and sometimes surgery, the addition of Culturelle Digestive Daily Probiotic Capsule offers a unique approach by introducing beneficial bacteria to the gut. Researchers are excited about this treatment because probiotics may help balance the body's microbiome, potentially reducing infection recurrence and improving overall recovery. This method harnesses the natural benefits of probiotics, which is a novel strategy in the context of joint infections, providing a complementary approach to enhance traditional treatments.

What evidence suggests that probiotics might be an effective treatment for prosthetic joint infection?

This trial will compare probiotics with standard care for prosthetic joint infections. Studies have shown that probiotics, like those in Culturelle Digestive Daily Probiotic Capsules, can reduce digestive issues such as gas, bloating, and diarrhea. Research suggests that using probiotics during surgery is safe and may help prevent infections, particularly in abdominal surgeries. Some evidence indicates that adding probiotics to antibiotics might enhance the treatment of infections in artificial joints. While results can vary, these findings offer hope that probiotics could improve outcomes for people with infections in prosthetic joints. Participants in this trial will receive either standard care alone or standard care with probiotic supplementation. ^{1 2 6 7 8}

Who Is on the Research Team?

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Patients who are critically ill

I have an ongoing heart infection.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-infections-3-2025-80452

Probiotics for Prosthetic Joint Infection · Info for Participants In a three-month study involving 29 patients with rheumatoid arthritis, probiotics did not show a statistically significant improvement in the ACR20 response ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06636669

Probiotics in the Prevention of Recurrent Prosthetic Joint ... Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery.

3. bu.trialstoday.org bu.trialstoday.org/trial/NCT06636669

Probiotics in the Prevention of Recurrent Prosthetic Joint ... Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators ...

4. culturelle.com culturelle.com/products/digestive-daily-probiotic?srsltid=AfmBOorpxTXuVlbyCsp5XuroPNKPnxNUuu0QgkjTxcMHJlBCJCV0GDD-

Digestive Daily Probiotic Capsules Clinically studied probiotic, Lactobacillus rhamnosus GG, reduces occasional digestive upset including gas, bloating and diarrhea.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11515416/

The effect of prebiotic fibre on the gut microbiome and surgical ... These data suggest that adding a prebiotic or probiotics as an adjuvant therapy to the antibiotic regimen may help treat PJI patients more effectively. None of ...

6. culturelle.com culturelle.com/products/digestive-daily-probiotic?srsltid=AfmBOopFdkhm5UswpAPuBcKisyfOl1Yyrj0ZrEwwEWNzH9DHlzmfX12W

Digestive Daily Probiotic Capsules The #1 clinically studied probiotic, Lactobacillus rhamnosus GG,† reduces occasional digestive upset including gas, bloating, and diarrhea.

7. culturelle.com culturelle.com/products/digestive-daily-probiotic?srsltid=AfmBOoqYii9_S6fanuFpxhCtDsGGE-hoGjYHgC-7yvmWTh2Z0ozPOOgb&variant=39930481082446&bvstate=pg:4/ct:r&srsltid=AfmBOooSMIESDtd3JG98rezWx9N9idoHyU3kEvkLr1-MC6dHXNUHw49L

Digestive Daily Probiotic Capsules The #1 clinically studied probiotic, Lactobacillus rhamnosus GG,† reduces occasional digestive upset including gas, bloating, and diarrhea.

8. dsld.od.nih.gov dsld.od.nih.gov/label/250859

Digestive Daily Probiotic - Dietary Supplement Label Database Help your digestive system work better & support your gut microbiome with the power of Culturelle Digestive Daily Probiotic. ... Take one capsule daily.