Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00977496
First received: September 14, 2009
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

The goal of this study is characterize the changes in bacterial diversity of the nares of hemodialysis patients. Another goal is to determine when hemodialysis patients become colonized with the bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be recruited into the study. Nasal swabs will be collected every month for six months or until one month after S. aureus colonization in order to determine any changes in the bacterial communities of the nose. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities in the patients' noses. This study will provide preliminary data on whether oral- and/or nasal-administered probiotics can eliminate nasal carriage of S. aureus.


Condition Intervention
Hemodialysis
Procedure: Nasal Swab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S Aureus

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • To describe the clinical variables that may be associated with the acquisition of S aureus nasal colonization, over a six-month period. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ] [ Designated as safety issue: No ]
  • To refine and test the feasibility of using non culture-based methods to study the microbial ecology and bacterial diversity of the anterior nares in patients starting hemodialysis using 16sRNA sequence analysis. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ] [ Designated as safety issue: No ]
  • To explore changes in bacterial diversity in the anterior nares over a six-month period and in conjunction with S aureus colonization. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2011
Groups/Cohorts Assigned Interventions
Nasal Swab
New chronic hemodialysis patients with no evidence of nasal carriage of Staphylococcus aureus from Boston Dialysis Center Inc., the outpatient hemodialysis clinic of Tufts Medical Center
Procedure: Nasal Swab
Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the anterior vestibule of both nares and processed for S aureus cultures and for bacterial DNA extraction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.

Criteria

Inclusion Criteria:

  • Male and female subjects aged 18 years or older
  • On a stable hemodialysis schedule three times a week at Tufts Medical Center outpatient hemodialysis unit
  • Able to speak English, Spanish, Cantonese, or Mandarin (One of these languages is spoken by >95% of our hemodialysis population)
  • Provides informed consent to participate in the study
  • No plans to be absent from the dialysis unit in the next 6 months
  • Willingness to report on adverse events during the study period

Exclusion Criteria:

  • Patients in which hemodialysis was indicated for acute renal failure secondary to septic shock, acute tubular necrosis, or other condition which is felt to be temporary or secondary to a life threatening illness or likelihood of hemodialysis for less than 6 months.
  • Treatment with systemic anti-staphylococcal antibiotic therapy within 30 days prior to enrollment or planned use of topical mupirocin applied to the nares
  • Receiving peritoneal dialysis (concordance between the colonizing and infecting strain is not as high as in the hemodialysis population (105))
  • Absolute neutrophil count less than 500/mm3 or anticipated fall in neutrophil count < 500/mm3 (e.g. as a result of recent chemotherapy)
  • Bleeding diathesis such as platelets count less than 20 or INR >4 within the last 30 days
  • On immunosuppressive therapy
  • Anticipated renal transplant during the next 6 months
  • Evidence of active bowel leak, acute abdomen or colitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977496

Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Patricia L Hibberd, MD, PhD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Patricia Hibberd, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00977496     History of Changes
Other Study ID Numbers: 8784
Study First Received: September 14, 2009
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
hemodialysis
microbiota
Staphylococcus aureus

ClinicalTrials.gov processed this record on July 20, 2014