Staphylococcus Aureus
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTBacillus subtilis probiotic
Bacillus probiotic which contains one confidential ingredient of Bacillus subtilis spores (2 x 1010 CFU/g). Over 5 days of interventional period, the patient receives one tablet (250 mg; 5 x 109 CFU) of probiotic per day.
OTHERPlacebo
Over 5 days of interventional period, the patient receives 1 placebo tablet per day
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Healthy volunteers
No
Inclusion criteria
1. Adults (age \>18 years) 2. Undergoing elective primary knee or hip arthroplasty 3. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing 4. Written informed consent
Exclusion criteria
1. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment 2. Antibiotic use within 3 months prior to enrollment 3. Active clinical infection 4. Participation in other clinical trials 5. Presence of pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent Staphylococcus aureus colonization | post-intervention: following 5 days of dietary supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in microbiome composition | post-intervention: following 5 days of dietary supplementation | as determine through next generation sequencing of samples collect from the patient |
Countries
United States
Outcome results
None listed