Clinical trial NCT06897800: Vaginal Microbiota and Its Association with Pap Smear Results, Human Papillomavirus, Vitamins, and Metabolic Mark
Official title: Correlations Between Cervial Pap Smear,Vaginal Microbiota, Human Papillomavirus and Index of Blood Vitamins and Metabolic Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Microbiome
Keywords: vaginal microbiome
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
First posted: 2025-03-27
Enrollment: 41
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be selected from patients attending the Family Medicine outpatient clinic at Cheng Hsin General Hospital.

Brief 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.

Eligibility criteria: Inclusion Criteria:

Participants must meet all of the inclusion criteria

* Female participants
* History of sexual activity
* Age 30 years or older

Exclusion Criteria:

* Participants will be excluded from the study if they meet any of the following conditions:
* Currently pregnant at the time of enrollment or before sample collection day.
* History of total hysterectomy.

Primary outcomes:
measure: Vaginal microbiome
timeFrame: Enrollment occurs at least 7 days before sampling. Participants must avoid menstruation, sex, douching, meds, and bathing within 24 hrs. All data collected in one visit within 2 hrs; study lasts within 2 weeks.
Secondary outcomes:
measure: Cervical specimen
timeFrame: All data were collected during a single clinical visit within 2 hours, following vaginal discharge collection. The study period from enrollment to completion was approximately 2 weeks per participant.
measure: blood, and urine samples
timeFrame: Blood and urine samples were collected on the scheduled sample collection day, prior to vaginal, and cervical specimen collection. All procedures were completed within 2 hours during the same clinical visit.Study duration was within 2 weeks.
measure: Anthropometric and Vital Measurements
timeFrame: Specimens were collected on the sample collection day, following completion of blood and urine sample collection. All procedures were completed within 2 hours during the same clinical visit.Study duration was within 2 weeks.
measure: questionnaire
timeFrame: The questionnaire was completed post-exam on the sample day, in 10-15 minutes. All procedures finished within 2 hours. Study duration was within 2 weeks per participant.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
Study officials:
References: