A Phase 4 interventional study of Probiotic and Standard of care in Prosthetic-joint Infection and Dysbiosis, sponsored by Boston Medical Center. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Boston Medical Center · Phase 4, Interventional, and Treatment
Among 44 studies in Dysbiosis with a site in United States — 14 open to participants now, 20 under way, none of them phase 3. Dysbiosis · United States.
Among the 44 studies in Dysbiosis with a site in United States, this one is the 2nd largest by planned enrollment of the 35 interventional ones, is one of 6 that started in 2025, is one of 5 in phase 4, reaches primary completion later than 12 of the 19 other live ones, and was the 33rd registered.
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
This study's planned enrollment of 152 is above the median of 60 across 132 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →14 of the 44 studies in Dysbiosis with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 41 Dysbiosis studies recruiting now, 14 (34%) set no upper age limit and 24 (59%) stop at 75 or younger; 10 take children under 18; 18 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 6 started in 2025.
Median enrollment 48 across the 35 interventional studies, 58 across the 8 observational. Of the 21 that completed or were terminated, 6 (29%) have results posted.
4 of 44 have an industry lead sponsor. The 10 most frequent:
Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Boston Medical Center has 2 studies filed under Dysbiosis — fewer than ten, so there is no comparison to draw.
8 of the studies in Dysbiosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06544954University of California, DavisPrebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women | 2026-11 |
| NCT06588218Florida State UniversityEffect of Watermelon on Gut and Cardiometabolic Health | 2026-12 |
| NCT05288790Vanderbilt University Medical CenterMicrobiome Metabolites and Alcohol in HIV to Reduce CVD RCT | 2027-03-31 |
| NCT06916936Florida State UniversityEffect of Peanut Butter on Gut and Metabolic Health | 2027-05 |
| NCT06636669Boston Medical CenterProbiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee | 2027-06 |
Among the 44 studies in Dysbiosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients scheduled to undergo revision total knee arthroplasty (TKA) or total hip arthroplasty (THA) for infection at the participating institutions will be screened for eligibility in this prospective trial.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized into this are will receive Culturelle probiotic and standard of care.
Drug: Probiotic · Other: Standard of care
Participants randomized into this are will receive standard of care.
Other: Standard of care
Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.
Also known as: Culturelle
Standard of care (SOC) treatment includes surgery and antimicrobials.
Recurrent Prosthetic Joint Infection (PJI)
The number of participants who develop PJI after PJI surgery will be abstracted from electronic medical records.
Time frame: 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.
Time frame: 3 months, 6 months, 12 months post PJI surgery
Medical complications
This outcome will be assessed from information in the electronic medical records and reported as Yes or No.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months, 6 months, 12 months post PJI surgery
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2027, 22 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic