Vaginal MicrobiomeNCT06897800
Vaginal Microbiota and Its Association with Pap Smear Results, Human Papillomavirus, Vitamins, and Metabolic Mark
An observational study of Vaginal Microbiome, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2022to 18 Aug 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study participants will be selected from patients attending the Family Medicine outpatient clinic at Cheng Hsin General Hospital.
Who may be able to join
- Participants must meet all of the inclusion criteria
- Female participants
- History of sexual activity
- Age 30 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Vaginal Microbiome
- Keywords
- vaginal microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start8 Sep 2022
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897800
- Sponsor's protocol ID
- (803)109A-42
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Cervial Pap Smear,Vaginal Microbiota, Human Papillomavirus and Index of Blood Vitamins and Metabolic Markers
- ClinicalTrials.gov ID
- NCT06897800
- Acronym / sponsor ID
- (803)109A-42
- Conditions
- Vaginal Microbiome
- Keywords
- vaginal microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 32 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants will be selected from patients attending the Family Medicine outpatient clinic at Cheng Hsin General Hospital.
Key inclusion criteria (4 listed)
- Participants must meet all of the inclusion criteria
- Female participants
- History of sexual activity
- Age 30 years or older
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaginal microbiome
Time frame: 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.
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.
4 secondary outcomes
Cervical specimen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Microbiome, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiome (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.