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

NCT ID: NCT00977496

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31

Brief Summary

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.

Conditions

Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Nasal Swab

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tufts Medical Center

Principal Investigators

Patricia L Hibberd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Other Identifiers

8784

Identifier Type: -

Identifier Source: org_study_id