Vaginal Microbiota
Conditions
Keywords
tampon, menstruation, menstrual period
Brief summary
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.
Interventions
DEVICETampon A
24 Tampax Pearl Regular Tampons for use during a single menstrual period.
DEVICETampon B
24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for one of the first two menstrual cycles during the study. Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the other of the first two menstrual cycle during the study. Subjects used tampons A and B in a randomly assigned order. Subjects then used tampons of their choosing for the third menstrual cycle of the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relative Abundance of Lactobacillus Species | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relative Abundance of Gardnerella Vaginalis | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tampon A First Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing. | 13 |
| Tampon B First Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing. | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Enrollment to Baseline Data Collected | Lost to Follow-up | 2 | 3 |
| First Menstrual Cycle | Withdrawal by Subject | 1 | 0 |
| Second Menstrual Cycle | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Tampon A First | Tampon B First | Total |
|---|---|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 5 | 24.3 years STANDARD_DEVIATION 4 | 26.1 years STANDARD_DEVIATION 4.9 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Relative abundance of Gardnerella vaginalis | .000091 relative abundance | .000019 relative abundance | .000045 relative abundance |
| Relative abundance of Lactobacillus species | .9667 relative abundance | .9727 relative abundance | .9705 relative abundance |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 | 0 / 21 |
Outcome results
Primary
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)
Population: Participants analyzed are those that provided samples through the end of the given menstrual cycle.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tampon A First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of first cycle | .0084 relative abundance |
| Tampon A First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of second cycle | -.00004 relative abundance |
| Tampon A First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of third menstrual cycle | -.0350 relative abundance |
| Tampon B First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of first cycle | -.0014 relative abundance |
| Tampon B First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of second cycle | .0104 relative abundance |
| Tampon B First | Change in Relative Abundance of Lactobacillus Species | Baseline to end of third menstrual cycle | .0238 relative abundance |
Secondary
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.
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)
Population: Participants analyzed are those that provided samples through the end of the given menstrual cycle.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tampon A First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to end of first cycle | .000046 relative abundance |
| Tampon A First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to end of second cycle | -.000045 relative abundance |
| Tampon A First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to 14 weeks | -.000045 relative abundance |
| Tampon B First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to end of first cycle | 0 relative abundance |
| Tampon B First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to end of second cycle | 0 relative abundance |
| Tampon B First | Change in Relative Abundance of Gardnerella Vaginalis | Baseline to 14 weeks | 0 relative abundance |