Examining the Impact of Tampon Use on the Vaginal Microbiota
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Relative Abundance of Lactobacillus Species
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tampon A (Device)
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.
干预措施: Tampon B (Device)
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.
干预措施: Tampon A (Device)
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.
干预措施: Tampon B (Device)
结局指标
主要结局
Change in Relative Abundance of Lactobacillus Species
时间窗: 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.
次要结局
- 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))
研究者
Jason Bell, MD, MPH, MS
Assistant Professor
University of Michigan