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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Microbiome

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal microbiome	The first swab of the vaginal secretion sample is tested for pH and glucose concentration using test strips in the clinic. The second swab is placed in a vial containing preservation solution. The label on the vial does not include the patient's name or medical record number but only indicates the sampling date and an identification number. The sample is temporarily stored at room temperature for one week in a lockable cabinet in the Family Medicine Department office. Subsequently, the sample is analyzed by a biotechnology company using mass cytometry and deep sequencing of bacterial 16S rRNA PCR to identify the various microbial communities present in the vaginal secretions.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical specimen	Participants underwent pelvic examination using an adjustable gynecological examination table. Disposable vaginal speculums and dedicated sampling swabs were used to ensure hygiene and standardization. Cervical cytology smears were interpreted by certified pathologists following the classification system provided by the Taiwan Health Promotion Administration. High-risk human papillomavirus (HR-HPV) genotyping included detection of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.	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.
blood, and urine samples	Participants underwent blood sampling after an 8-hour overnight fast for biochemical and nutritional assessments. The tests included complete blood count (CBC), white blood cell differential count, fasting blood glucose, glycated hemoglobin (HbA1c), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides, C-reactive protein (CRP), vitamin A, vitamin D, vitamin E, vitamin B12, zinc, folate, serum iron, ferritin, total protein, albumin, and tumor marker CA125.	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.
Anthropometric and Vital Measurements	Participants underwent anthropometric and Vital Measurements include height, weight, waist circumference, body fat percentage, and blood pressure values.	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.
questionnaire	The questionnaire included items related to past medical conditions and vaccination history, current medication and supplement use, tobacco, alcohol, and betel nut use, dietary habits, menstrual cycle and sexual experience, and hygiene product usage patterns.	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.

Collaborators and Investigators

• Sponsor: Cheng-Hsin General Hospital
• Collaborators: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: vaginal microbiome
• Other Study ID Numbers: (803)109A-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No