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Probiotics Pilot Project

Primary Purpose

Staphylococcus Aureus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bacillus subtilis probiotic
Placebo
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcus Aureus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

No intervention

Arm Description

Outcomes

Primary Outcome Measures

Persistent Staphylococcus aureus colonization

Secondary Outcome Measures

Changes in microbiome composition
as determine through next generation sequencing of samples collect from the patient

Full Information

First Posted
January 28, 2020
Last Updated
February 18, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04247854
Brief Title
Probiotics Pilot Project
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Anticipated)
Study Completion Date
January 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Bacillus subtilis probiotic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Over 5 days of interventional period, the patient receives 1 placebo tablet per day
Primary Outcome Measure Information:
Title
Persistent Staphylococcus aureus colonization
Time Frame
post-intervention: following 5 days of dietary supplementation
Secondary Outcome Measure Information:
Title
Changes in microbiome composition
Description
as determine through next generation sequencing of samples collect from the patient
Time Frame
post-intervention: following 5 days of dietary supplementation

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (age >18 years) Undergoing elective primary knee or hip arthroplasty Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing Written informed consent Exclusion Criteria: Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment Antibiotic use within 3 months prior to enrollment Active clinical infection Participation in other clinical trials Presence of pregnancy or lactation
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Probiotics Pilot Project

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