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Friendly bacteria may fight off repeat joint infections

NCT ID NCT06636669

Prevention Sponsor: Boston Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether taking a daily probiotic alongside standard antibiotic treatment after surgery for an infected hip or knee joint can lower the chance of the infection coming back. The study involves 152 adults undergoing revision joint replacement for infection. Half will receive standard care, and half will receive standard care plus a probiotic for the duration of their antibiotic course and a week beyond. The main goal is to see if the probiotic reduces the need for another surgery due to recurrent infection within a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Probiotic (Culturelle)
What this could lead to
If effective, adding probiotics to standard care could reduce the risk of repeat joint infections after hip or knee replacement surgery, improving outcomes and reducing the need for further operations.
What could go wrong
This is a relatively small trial, and results may not apply to all patients. Probiotics are generally safe but can rarely cause infections in people with weakened immune systems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 152 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Dysbiosis periprosthetic joint infection Reinfection Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysbiosis Prosthetic joint infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Center, Orthopedic Surgery

    Boston, Massachusetts, 02118, United States

  • New York University Langone Orthopedics

    New York, New York, 10016, United States

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