Probiotics Pilot Project

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Staphylococcus Aureus

Treatments: Other: Placebo; Dietary Supplement: Bacillus subtilis probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04247854

2020-01 JP

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Treatment:

Dietary Supplement: Bacillus subtilis probiotic

No intervention

Placebo Comparator group

Treatment:

Other: Placebo