Examining the Impact of Tampon Use on the Vaginal Microbiota

Study Overview
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Brief Summary
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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.

Official Title
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Examining the Impact of Tampon Use on the Vaginal Microbiota

Conditions
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Vaginal Microbiota

Intervention / Treatment
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* Device: Tampon A
* Device: Tampon B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tampon A First<br>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. | Device: Tampon A<br>* 24 Tampax Pearl Regular Tampons for use during a single menstrual period.<br>Device: Tampon B<br>* 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.<br>|
| Experimental: Tampon B First<br>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. | Device: Tampon A<br>* 24 Tampax Pearl Regular Tampons for use during a single menstrual period.<br>Device: Tampon B<br>* 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tampon, menstruation, menstrual period