Probiotics Pilot Project

Rothman Institute Orthopaedics20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Staphylococcus Aureus

Interventions

Bacillus subtilis probioticDIETARY_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.

PlaceboOTHER

Over 5 days of interventional period, the patient receives 1 placebo tablet per day

Eligibility

Medical Language ↔ Plain English

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

Locations (1)

Rothman Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Persistent Staphylococcus aureus colonization

Time frame: post-intervention: following 5 days of dietary supplementation

Secondary Outcomes

Changes in microbiome composition

as determine through next generation sequencing of samples collect from the patient

Time frame: post-intervention: following 5 days of dietary supplementation

Data from ClinicalTrials.gov

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