Microbiological Impact of a Cream and the Feeling of Softness and Freshness in the Intimate Area of Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Presence of at least one LN bacteria strain in the intimate area of women in the intervention group
研究概览
简要总结
Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after (9-11 days) finished crème-usage.
The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women with use of a probiotic creme.
详细描述
The rational for using probiotics is that the humans are colonized by a numbers of microorganisms from birth. These microorganisms are the natural flora of the human body. This bacterial ecology may be imbalanced due different circumstances: excessive hygiene, use of antibiotics or other drugs, use of alcohol, smoking, stress, diabetes and many other factors. The natural bacterial flora in the external part of the genital tract might be promoted by help of intimate products containing probiotics.
The study objectives Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before and at the end of a 10 days crème-usage (day 8-10), as well as 10 (9-11) days after finished crème-usage.
The primary endpoint of the study Presence of at least one LN bacteria strain in the intimate area of women in the intervention group compared to the intimate area of women in the control group at the end of a 10 days crème-usage (Day 8-10), as well as 10 (9-11) days after finished crème-usage. The primary endpint will be measured by bacterial Culture.
None-parametric statistical analyses.
Secondary endpoints Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area before and at the end of the 10 days crème-usage (Day 8-10), as well as 10 days after finished crème-usage (9-11 days after).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy women 45-65 years old
- •with subjective dryness in the intimate area
- •postmenopausal with last menstruation more than or equal to 3 years prior to entering the study
- •being willing to abstain sexual intercourse during the study period
排除标准
- •yeast infection or bacterial vaginosis
- •use of antibiotics or antifungals
- •use of estrogen
- •participation in Another study
研究组 & 干预措施
Probiotic creme
Women receing probiotic creme
干预措施: probiotic creme (Device)
placebo
Women receiving a moisturizer
干预措施: Placebo (Drug)
结局指标
主要结局
Presence of at least one LN bacteria strain in the intimate area of women in the intervention group
时间窗: the end of a 10 days crème-usage
Bacterial Culture of LN bacterial strains
次要结局
- subjective feeling of dryness and freshness in the intimate of women(the end of the 10 days crème-usage (Day 8-10) and 10 days after finished crème-usage (9-11 days after))
- Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area(at the end of creme usage and 10 days after finished crème-usage (9-11 days after).)
研究者
Helena Kopp Kallner
Consultant, MD, PhD
Karolinska Institutet