Prosthetic-joint InfectionPhase 4NCT06636669
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
A Phase 4 study testing Probiotic in people with Prosthetic-joint Infection and Dysbiosis, run by Boston Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prosthetic-joint Infection, Dysbiosis
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2025to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
- Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision TJA for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.
- 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.
Who cannot join
- Fungal PJI.
- Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal
- issue where there is concern for gut integrity.
- History of pancreatitis at any point in time.
- History of intolerance to probiotics.
- Immunocompromised patients.
- Revision TJA for aseptic reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Boston Medical Center, Orthopedic Surgery
Boston, Massachusetts, 02118
New York University Langone Orthopedics
New York, New York, 10016
About this study
Official title: The Role of Peri-operative Adjunctive Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
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.
Read the detailed description
The primary and secondary aims for this RCT are:
Primary Aim 1.1 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates (deep infection) within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
Secondary Aims 2.1 To evaluate the incidence of superficial infections including wound drainage, cellulitis, or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
2.2 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI.
2.3 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).
2.4 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).
2.5 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
2.6 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms (probiotics and standard of care). The risk of developing C. difficile infection is present for 90 days following cessation of antibiotic treatment.
- Conditions
- Prosthetic-joint Infection, Dysbiosis
- Being tested
- Probiotic, Standard of care
- Keywords
- Probiotics, Hip total joint arthroplasty (TJA), Knee TJA, Recurrent reinfection, DAIR, Surgical site infection (SSI), Patient Reported Outcome Measures (PROMs)
- Medical subject headings
- Dysbiosis, Reinfection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Also called Culturelle
Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.
Standard of careOther
Standard of care (SOC) treatment includes surgery and antimicrobials.
| Study group | Role | What they receive |
|---|---|---|
| Treatment- Probiotics and standard of care | Experimental | Participants randomized into this are will receive Culturelle probiotic and standard of care. Receives: Drug: Probiotic; Other: Standard of care |
| Controls- Standard of care | Active comparator | Participants randomized into this are will receive standard of care. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Prosthetic Joint Infection (PJI)
The number of participants who develop PJI after PJI surgery will be abstracted from electronic medical records.
Measured: 1 year, 2 years after PJI surgery
Surgical Site Infection (SSI)
The number of participants who develop SSI within 12 months of PJI surgery will be abstracted from electronic medical records.
Measured: 3 months, 6 months, 12 months post PJI surgery
Secondary outcomes (10)
Medical complications
This outcome will be assessed from information in the electronic medical records and reported as Yes or No.
Measured: 3 months, 6 months, 12 months post PJI surgery
Surgical complications
This outcome will be assessed from information in the electronic medical records and reported as Yes or No.
Measured: 3 months, 6 months, 12 months post PJI surgery
Sepsis
The number of participants who have a diagnosis of sepsis related to PJI surgery will be abstracted from electronic medical records.
Measured: 3 months, 6 months, 12 months post PJI surgery
Re-operation for recurrent infection
The number of participants who have a re-operation for recurrent infection within 12 months of the PJI surgery will be abstracted from the electronic medical records.
Measured: 3 months, 6 months, 12 months post PJI surgery
Revision surgery
The number of participants who have revision surgery within 12 months of PJI surgery will be abstracted from electronic medical records.
Measured: 3 months, 6 months, 12 months post PJI surgery
Complications related to the use of probiotics
This outcome will be assessed from information in the electronic medical records and reported as Yes or No.
Measured: 3 months, 6 months, 12 months post PJI surgery
Mortality
The number of participants who die within 12 months of the PJI surgery will be abstracted from the electronic medical records.
Measured: 12 months post PJI surgery
Patient reported health outcomes
The Patient-Reported Outcomes Measurement Information System (PROMIS)-10 score ranges from 0 to 20 points, with 0 representing the most severe impairment and 20 representing the best possible health. Low scores may indicate poorer self-reported health and a greater risk of future healthcare utilization.
Measured: 3 months, 6 months, 12 months post PJI surgery
Patient reported hip disability
The Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) will be used to assess hip disability. It is patient reported and contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table where the interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Measured: 3 months, 6 months, 12 months post PJI surgery
Patient reported knee disability
Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) will be used to assess knee disability. It is patient reported and contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table.. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Measured: 3 months, 6 months, 12 months post PJI surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centered, randomized controlled trial (RCT) with two arms will be conducted at two academic, tertiary care centers.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Responsible party
- Sponsor
- Investigators
- Ayesha Abdeen, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636669
- Sponsor's protocol ID
- H-44452
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Peri-operative Adjunctive Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
- ClinicalTrials.gov ID
- NCT06636669
- Acronym / sponsor ID
- H-44452
- Conditions
- Prosthetic-joint Infection, Dysbiosis
- Keywords
- Probiotics, Hip total joint arthroplasty (TJA), Knee TJA, Recurrent reinfection, DAIR, Surgical site infection (SSI), Patient Reported Outcome Measures (PROMs)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary and secondary aims for this RCT are:
Primary Aim 1.1 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates (deep infection) within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
Secondary Aims 2.1 To evaluate the incidence of superficial infections including wound drainage, cellulitis, or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
2.2 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI.
2.3 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).
2.4 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).
2.5 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).
2.6 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms (probiotics and standard of care). The risk of developing C. difficile infection is present for 90 days following cessation of antibiotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-centered, randomized controlled trial (RCT) with two arms will be conducted at two academic, tertiary care centers.
| Arm | Type | Receives |
|---|---|---|
| Treatment- Probiotics and standard of care | Experimental | Drug: Probiotic, Other: Standard of careParticipants randomized into this are will receive Culturelle probiotic and standard of care. |
| Controls- Standard of care | Active comparator | Other: Standard of careParticipants randomized into this are will receive standard of care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
- Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision TJA for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.
- 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.
Key exclusion criteria (7 listed)
- Fungal PJI.
- Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal
- issue where there is concern for gut integrity.
- History of pancreatitis at any point in time.
- History of intolerance to probiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: CulturelleCulturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment. | Drug | Treatment- Probiotics and standard of care |
| Standard of careStandard of care (SOC) treatment includes surgery and antimicrobials. | Other | Controls- Standard of care, Treatment- Probiotics and standard of care |
Primary outcome
Recurrent Prosthetic Joint Infection (PJI)
Time frame: 1 year, 2 years after PJI surgery
The number of participants who develop PJI after PJI surgery will be abstracted from electronic medical records.
Surgical Site Infection (SSI)
Time frame: 3 months, 6 months, 12 months post PJI surgery
The number of participants who develop SSI within 12 months of PJI surgery will be abstracted from electronic medical records.
10 secondary outcomes
Medical complications
Time frame: 3 months, 6 months, 12 months post PJI surgery
Surgical complications
Time frame: 3 months, 6 months, 12 months post PJI surgery
Sepsis
Time frame: 3 months, 6 months, 12 months post PJI surgery
Re-operation for recurrent infection
Time frame: 3 months, 6 months, 12 months post PJI surgery
Revision surgery
Time frame: 3 months, 6 months, 12 months post PJI surgery
Complications related to the use of probiotics
Time frame: 3 months, 6 months, 12 months post PJI surgery
Mortality
Time frame: 12 months post PJI surgery
Patient reported health outcomes
Time frame: 3 months, 6 months, 12 months post PJI surgery
Patient reported hip disability
Time frame: 3 months, 6 months, 12 months post PJI surgery
Patient reported knee disability
Time frame: 3 months, 6 months, 12 months post PJI surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Abdeen, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic in people with Prosthetic-joint Infection and Dysbiosis, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Prosthetic Joint Infection (PJI) (time frame: 1 year, 2 years after PJI surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.