Examining the Impact of Tampon Use on the Vaginal Microbiota

Vaginal Microbiota Clinical Trial

Official title:

Examining the Impact of Tampon Use on the Vaginal Microbiota

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346759
• Other study ID #: HUM00122922
• Status: Completed
• Phase: Phase 4
• Start date: February 20, 2017
• Est. completion date: September 11, 2017

Study information

• Verified date: July 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 11, 2017
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Microbiota

Intervention

Device:
• Tampon A
24 Tampax Pearl Regular Tampons for use during a single menstrual period.
• Tampon B
24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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)