Clinical Trials Directory

Trials / Completed

CompletedNCT06897800

Vaginal Microbiota and Its Association with Pap Smear Results, Human Papillomavirus, Vitamins, and Metabolic Mark

Correlations Between Cervial Pap Smear,Vaginal Microbiota, Human Papillomavirus and Index of Blood Vitamins and Metabolic Markers

Status
Completed
Phase
Study type
Observational
Enrollment
41 (actual)
Sponsor
Cheng-Hsin General Hospital · Academic / Other
Sex
Female
Age
32 Years – 75 Years
Healthy volunteers
Accepted

Summary

The human microbiome, comprising bacteria, fungi, and viruses, plays a crucial role in host physiology, immune function, and disease susceptibility. While gut microbiota have been extensively studied, other sites, including the vaginal microbiome, exhibit distinct microbial compositions. The vaginal microbiome is typically dominated by Lactobacillus species, which contribute to vaginal health but fluctuate with hormonal changes, menopause, and metabolic factors. This study analyzes the vaginal microbiome of 40 adult women using 16S rRNA sequencing and classifies them into Vaginal Community State Types (CSTs). CST IV, associated with dysbiosis, was most prevalent (55%). Postmenopausal women exhibited higher vaginal pH and increased CST IV prevalence (70%), while premenopausal women had more CST III (45%). SGLT2 inhibitor users showed higher beneficial CSTs (I, II) and lower CST IV. Findings suggest strong links between vaginal microbiota, menopause, glycemic control, and antibiotic use, highlighting the need for targeted interventions to maintain vaginal health.

Detailed description

Vaginal Microbiome, pH, Menopause, and Metabolic Factors The human body is colonized by a vast array of symbiotic, commensal, and pathogenic microorganisms, including bacteria, fungi, and viruses. The relationship between these microorganisms and the host varies from mutualistic and commensal to pathogenic interactions, collectively referred to as the microbiome. The human microbiome resides on both external and internal surfaces of the body, playing a critical role in physiology, immune system development, digestion, and detoxification. The metagenome of bacterial populations within the human body contains at least 100 times more genes than the human genome, underscoring its crucial role in maintaining homeostasis and influencing disease pathogenesis. The majority of bacterial communities reside in the gut, and over the past two decades, research has extensively focused on colonic microbiota, revealing intricate connections between gut microbes and various systemic physiological and pathological conditions. However, other anatomical sites, including the skin, oral cavity, urinary, and reproductive tracts, also host distinct microbial communities, which significantly differ from gut microbiota. The vaginal microbiome, in particular, is unique in that it is typically dominated by a single species of Lactobacillus, which is considered a hallmark of vaginal health. The composition of the vaginal microbiome is dynamic and changes across different life stages, influenced by hormonal fluctuations, menopause, metabolic factors, and external environmental factors. This study employs 16S rRNA gene sequencing to comprehensively analyze the distribution of vaginal microbiota and their associations with lifestyle, metabolic conditions, and disease susceptibility, with the ultimate goal of optimizing women's health. Recent studies have increasingly adopted the classification of vaginal microbial communities using the concept of Vaginal Community State Types (CSTs), a framework proposed by Ravel in 2011. This study investigates the microbial composition of 40 adult female participants, categorizing their vaginal microbiomes into CST I, CST II, CST III, and CST IV.

Conditions

Timeline

Start date
2022-09-08
Primary completion
2023-08-18
Completion
2023-08-18
First posted
2025-03-27
Last updated
2025-03-27

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06897800. Inclusion in this directory is not an endorsement.