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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator |
| |
| No intervention | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus subtilis probiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Staphylococcus aureus colonization | post-intervention: following 5 days of dietary supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microbiome composition | as determine through next generation sequencing of samples collect from the patient | post-intervention: following 5 days of dietary supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Placebo | Other | Over 5 days of interventional period, the patient receives 1 placebo tablet per day |
|