Examining the Impact of Tampon Use on the Vaginal Microbiota

• ClinicalTrials.gov Identifier: NCT03346759
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Results First Posted: July 20, 2018
• Last Update Posted: August 23, 2018
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Jason Bell, MD, MPH, MS, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vaginal Microbiota	Device: Tampon A; Device: Tampon B	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Examining the Impact of Tampon Use on the Vaginal Microbiota
• Actual Study Start Date: February 20, 2017
• Actual Primary Completion Date: September 11, 2017
• Actual Study Completion Date: September 11, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: Tampon A; 24 Tampax Pearl Regular Tampons for use during a single menstrual period.; Device: Tampon B; 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.
Experimental: 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.	Device: Tampon A; 24 Tampax Pearl Regular Tampons for use during a single menstrual period.; Device: Tampon B; 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.

Outcome Measures

Primary Outcome Measures :

1. Change in Relative Abundance of 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) ]
   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 Outcome Measures :

1. Change in Relative Abundance of 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Jason Bell, MD; University of Michigan

  Study Documents (Full-Text)

Documents provided by Jason Bell, MD, MPH, MS, University of Michigan:

Study Protocol and Statistical Analysis Plan  [PDF] March 29, 2018

More Information

• Responsible Party: Jason Bell, MD, MPH, MS, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03346759
• Other Study ID Numbers: HUM00122922
• First Posted: November 17, 2017
• Results First Posted: July 20, 2018
• Last Update Posted: August 23, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jason Bell, MD, MPH, MS, University of Michigan:

tampon; menstruation; menstrual period