UnknownNot Applicable

Probiotics Pilot Project

United States20 participantsStarted 2020-02-12

Plain-language summary

This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.

Who can participate

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults (age \>18 years)
. Undergoing elective primary knee or hip arthroplasty
. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
. Written informed consent

Exclusion criteria

. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
. Antibiotic use within 3 months prior to enrollment
. Active clinical infection
. Participation in other clinical trials
. Presence of pregnancy or lactation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Persistent Staphylococcus aureus colonization

Timeframe: post-intervention: following 5 days of dietary supplementation

Trial details

NCT IDNCT04247854

SponsorRothman Institute Orthopaedics

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-22

View on ClinicalTrials.gov More Staphylococcus Aureus trials

Who can participate

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults (age \>18 years)
. Undergoing elective primary knee or hip arthroplasty
. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
. Written informed consent

Exclusion criteria

. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
. Antibiotic use within 3 months prior to enrollment
. Active clinical infection
. Participation in other clinical trials
. Presence of pregnancy or lactation