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

NCT06897800 | Completed

• 1 other identifier: (803)109A-42
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Microbiome

Keywords

vaginal microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cervical specimen

  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

  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

  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 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.

Eligibility Criteria

• Age: 32 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead
• Taipei Medical University: collaborator

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taiwan, 112, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

vaginal discharge , cervical pap smear and blood serum

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: September 8, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

TW (1)