Examining the Impact of Tampon Use on the Vaginal Microbiota

University of Michigan28 enrolled

Overview

The vaginal microbiota is the community of bacteria in the vagina. The composition of the vaginal microbiota (which bacteria are present and how many of each are present) is known to affect vaginal health and contribute to the development of bacterial vaginosis (the largest cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also known that the composition of the vaginal microbiota changes across a menstrual cycle with the largest changes happening during a woman's period. However, it is not know how tampon use affects vaginal microbiota composition. This study is being done to learn what effect tampon use has on vaginal microbiota composition during a woman's period and between periods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Vaginal Microbiota

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * regular menstrual cycles lasting 21-35 days * menses lasting for at least 4 days * current tampon user * good self-reported general health * good self-reported vaginal health Exclusion Criteria: * currently pregnant * planning to become pregnant in 4 months following enrollment * difficulty using tampons * current toxic shock syndrome * history of toxic shock syndrome * current sexually transmitted infection * current urinary tract infection * currently using antibiotics * antibiotic use in 4 weeks prior to enrollment * current antifungal use * antifungal use in 4 weeks prior to enrollment * autoimmune condition

Outcomes

Primary Outcomes

Change in Relative Abundance of Lactobacillus Species

The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.

Time frame: Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)

Secondary Outcomes

Change in Relative Abundance of Gardnerella Vaginalis

The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.