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Probiotics Pilot Project

NCT04247854 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-20

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus

Interventions

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2021-01-22
Completion
2021-01-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247854 on ClinicalTrials.gov