Probiotics for Prosthetic Joint Infection

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether probiotics (beneficial bacteria that aid digestion and immune health) can reduce the risk of recurrent infections in individuals with a history of prosthetic joint infection (PJI) in the hip or knee. Current treatments involve surgery and antibiotics, but these do not always prevent recurrence. Participants will receive either the standard treatment or the standard treatment plus probiotics to evaluate the potential benefits of probiotics. Individuals who have experienced a PJI, are planning surgery for it, and are open to trying probiotics may be suitable candidates for this trial. As a Phase 4 trial, this research examines how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for probiotics in this treatment?

Research shows that probiotics are generally safe and easy for most people to handle. Studies have found that probiotics can be safely used during surgeries to help prevent infections, including those in the abdomen. Specifically, administering probiotics around the time of surgery has proven effective and safe for preventing infections.

For infections related to prosthetic joints, recent research supports the safety of probiotics. An ongoing study with 59 participants has reported no major safety issues so far. This suggests that probiotics are a safe option for those considering participation in a trial focused on prosthetic joint infections.

In summary, based on current data, probiotics have a good safety record. They are considered low-risk and are already used in other medical situations to help prevent infections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using probiotics for prosthetic joint infections because probiotics offer a unique approach by promoting beneficial bacteria to help fight infections naturally. Unlike standard antibiotics that aim to kill bacteria directly, probiotics like Culturelle can enhance the body's natural defenses, potentially reducing harmful bacteria without contributing to antibiotic resistance. This natural method could lead to new ways of managing infections while preserving the body's microbiome balance.

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

This trial will compare the use of probiotics with standard care for prosthetic joint infections. Research suggests that probiotics might help reduce infections after joint replacement surgeries. Studies have found a link between an unhealthy gut (the bacteria in the digestive system) and a higher risk of joint infections. Probiotics can help restore a healthy balance in the gut, potentially lowering the risk of infections. In other types of surgeries, probiotics have effectively prevented infections. Although the specific effect on joint infections is still under study, probiotics show promise in reducing re-infection rates after surgery. Participants in this trial will receive either probiotics alongside standard care or standard care alone. ^{1 2 6 7 8}

Who Is on the Research Team?

Ayesha Abdeen, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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

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

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

Exclusion Criteria

History of intolerance to probiotics

My immune system is weakened.

I have had pancreatitis before.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12015178/

The hidden connection between gut microbiota and ... This paper suggests that there could be a connection between periprosthetic joint infections and a compromised gut microbiome.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424000117

The influence of gut microbiome on periprosthetic joint ... It has been hypothesized that microbiome dysbiosis may increase the risk of periprosthetic joint infection by facilitating bacterial translocation.

3. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-024-01034-z

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 ...

4. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(25)00121-1/fulltext

Role of gut microbiota disruption in prosthetic joint infection The findings of this Review suggest that gut dysbiosis could be a modifiable risk factor for PJI, warranting the exploration of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11023614/

The Microbial Revolution in the World of Joint ... There is evidence that the gut microbiota plays a role in maintaining bone mineral density, which can contribute to osseointegration, osteolysis, aseptic ...

6. 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. The investigators hypothesize that ...

7. journals.asm.org journals.asm.org/doi/10.1128/aac.00338-25

Advancing the management of prosthetic joint infections As of October 2024, interim safety data from 59 enrolled participants have been reported. ... Preoperative synovial fluid cultures confirmed ...

8. jbji.copernicus.org jbji.copernicus.org/articles/10/85/2025/jbji-10-85-2025.pdf

The hidden connection between gut microbiota and ... Total joint arthroplasty is a safe and effective procedure for improving the quality of life and restoring function in patients affected by end- ...