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Probiotics Pilot Project

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

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Dietary Supplement: Bacillus subtilis probiotic Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Persistent Staphylococcus aureus colonization [ Time Frame: post-intervention: following 5 days of dietary supplementation ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247854


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04247854    
Other Study ID Numbers: 2020-01 JP
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections