Probiotics Pilot Project

Not Applicable

• Conditions: Staphylococcus Aureus
• Interventions: Other: Placebo; Dietary Supplement: Bacillus subtilis probiotic

• Registration Number: NCT04247854
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Status Verified: 2020-02
• Study Start: 2020-02-12
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No intervention	Placebo	-
Probiotic	Bacillus subtilis probiotic	-

Primary Outcome Measures

Name	Time	Method
Persistent Staphylococcus aureus colonization	post-intervention: following 5 days of dietary supplementation

Secondary Outcome Measures

Name	Time	Method
Changes in microbiome composition	post-intervention: following 5 days of dietary supplementation	as determine through next generation sequencing of samples collect from the patient

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States