An observational study in Hemodialysis, sponsored by Tufts Medical Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Tufts Medical Center · Observational
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.
Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.
Exclusion Criteria:
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.
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
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
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
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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