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Study Description

Archived self-collected vaginal swabs were utilized from a pilot study of vaginal douching cessation (NIH/NIAID R03-AI061131). Thirty-nine non-pregnant, reproductive-age women who reported the use of vaginal douche products in the two months prior to screening were enrolled. Thirty-three of these successfully completed the 16-week longitudinal study. Participants self-collected vaginal swabs and smears twice weekly. We report sequences based on the analysis of 16S rRNA gene sequences amplified from whole genomic DNA isolated from the swabs. Bacterial vaginosis (BV) is defined by Gram's stain of vaginal fluid (Nugent's score =7).

The large body of information generated will facilitate understanding of vaginal microbial community dynamics, the etiology of BV, and drive the development of better diagnostic tools for BV. Furthermore, it is hoped that the information will enable a more personalized treatment of BV and ultimately, prevent adverse sequelae associated with BV.

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Study Inclusion/Exclusion Criteria

Inclusion criteria were female age 18 years or older, non-pregnant, report of regular menstrual cycle, used a vaginal douche in the 2 months before screening, be willing to abstain from vaginal douching, and read English language at an 8th grade level. Women who tested positive for Neisseria gonorrhoeae or Chlamydia trachomatis at the baseline visit were permitted study enrollment after completing antibiotic treatment.

Study History

Study enrollment dates: December 2005 - June 2007

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Study Attribution
  • Principal Investigators
    • Jacques Ravel, PhD. Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.
    • Larry J. Forney, PhD. Department of Biological Sciences, University of Idaho, Moscow, ID, USA.
  • Co-Investigators
    • Rebecca M. Brotman, PhD, MPH. Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.
    • Jane Schwebke, MD. Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Funding Sources
    • UH2 AI083264. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.