Vaginal Microbial Ecology and Comparative Analysis between Post-Menopausal and Pre-Menopausal Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This observational study aims at identifying and comparing the vaginal microbiota of healthy post-menopausal and pre-menopausal women. The justification of carrying out this research is informed by a number of important factors:
Scientific Reasoning: The existing literature suggests that there is a significant change in the microbiome composition of the vagina that is linked to menopausal transition. Nevertheless, to create a baseline of microbiota characterization operating between diverse populations would be required to develop standardized characterizations of these alterations, which might be utilized as predictive biomarkers of menopausal condition and the associated morbidity.
Clinical Implications: The differences in vaginal microbiome between pre and post-menopausal women can help us understand the pathophysiology of GSM as well as design customized measures to restore microbial balance and reduce the symptoms of the menopausal period. This knowledge has the potential to change menopausal healthcare into aggressive instead of reactive, precision-focused care.
Methodology: Whole genome shotgun metagenomic sequencing allows the extensive, culture- independent characterization of the vaginal microbiota composition. This molecular method offers a comprehensive taxonomic distinction and enables the grouping of samples into Community State Type (CSTs) that have been confirmed as clinically meaningful groupings of vaginal microbiome profiles.
Sample Size Consideration: The suggested sample of 50 (25 in each group) implies a useful preliminary study that can give useful preliminary information on the effect size and can guide further studies that are larger and sufficiently powered. Although larger sample sizes are usually necessary to identify weakly differing species in microbiome studies, such a scale will be suitable to detect strong compositional dissimilarities between groups in dominant taxa and measures of diversity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy individuals with no known chronic illness.
- •For post-menopausal group: more than or equal to 12 months amenorrhea (not explained by pregnancy or other medical cause).
- •For pre-menopausal group: currently pre-menopausal (menstruating) sampling not during menses.
- •Willing to abstain from vaginal intercourse, douching, or intravaginal products for 48 hours prior to sampling.
- •Willing to provide written informed consent.
排除标准
- •Current menstruation (sampling must be rescheduled).
- •Pregnancy or breastfeeding.
- •Use of intravaginal antibiotics, antifungals, or probiotic suppositories within the past 2 weeks.
- •Vaginal douching or intravaginal product use in the past 48 hours.
- •Current symptomatic vaginal infection (pruritus, abnormal discharge, odour) or clinically diagnosed vaginitis at screening.
- •Active sexually transmitted infection diagnosed within past 3 months (self-report or medical history).
- •Major gynecologic surgery within 3 months.
- •Chronic illness such as Type 2 diabetes, Hypertension.
研究者
Dr Abhishek Aggarwal
Sri Laxmi Hospital