Probiotics Pilot Project

Staphylococcus Aureus Clinical Trial

Official title:

Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04247854
• Other study ID #: 2020-01 JP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: February 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Staphylococcus Aureus

Intervention

Dietary Supplement:
• Bacillus 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.

Other:
• Placebo
Over 5 days of interventional period, the patient receives 1 placebo tablet per day

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Staphylococcus aureus colonization		post-intervention: following 5 days of dietary supplementation
Secondary	Changes in microbiome composition	as determine through next generation sequencing of samples collect from the patient	post-intervention: following 5 days of dietary supplementation