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Probiotics Pilot Project

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ClinicalTrials.gov Identifier: NCT04247854
Recruitment Status : Unknown
Verified February 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : January 30, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE February 12, 2020
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
Persistent Staphylococcus aureus colonization [ Time Frame: post-intervention: following 5 days of dietary supplementation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics Pilot Project
Official Title  ICMJE Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Staphylococcus Aureus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Probiotic
    Intervention: Dietary Supplement: Bacillus subtilis probiotic
  • Placebo Comparator: No intervention
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 22, 2021
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04247854
Other Study ID Numbers  ICMJE 2020-01 JP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP