Probiotics Pilot Project

February 18, 2020 updated by: Rothman Institute Orthopaedics

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
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.
Placebo Comparator: No intervention
Other: Placebo
Over 5 days of interventional period, the patient receives 1 placebo tablet per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistent Staphylococcus aureus colonization
Time Frame: post-intervention: following 5 days of dietary supplementation
post-intervention: following 5 days of dietary supplementation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Anticipated)

January 22, 2021

Study Completion (Anticipated)

January 22, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01 JP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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