Intestinal MicrobiotaNCT05003505
Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection
An observational study of Intestinal Microbiota and Vaginal Microbiota, run by Fujian Maternity and Child Health Hospital at 8 sites in China.
Trial summary
There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Microbiota, Vaginal Microbiota, HPV Infection
- What is being tested?
- Follow up
- How many people
- 651 participants
- Where
- 8 sitesChina
- Study dates
- 1 Jul 2021to 31 Dec 2024
- How long will I take part?
- 24 Months
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese women aged 20-65 years with abnormal cervical cytology.
Who may be able to join
- Women aged 20-65.
- TCT examination was performed in the last 3 months with abnormal results.
- Non pregnant people with sexual history.
- Asexual life, no vaginal medication or flushing before 72 hours of sampling.
Who cannot join
- Within 8 weeks after pregnancy or postpartum.
- Patients with history of genital tract tumor.
- History of HPV vaccination.
- Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
- In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
- Use antibiotics or vaginal microecological improvement products in recent 1 month.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Shunde Women's and Children's Hospital of Guangdong Medical University
Foshan, Guangdong
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Mindong Hospital of Ningde City
Ningde, Fujian, 352000
Quanzhou First Hospital Afflicated to Fujian Medical University
Quanzhou, Fujian, 362000
Maternal and Child Health Hospital of Shenzhen Province
Shenzhen, Guangdong
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei
Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363000
About this study
Official title: Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection
There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.
Read the detailed description
Based on the clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, five research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University and Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University were included, each of which included 600 individuals, with a total of 3000 women with potential cervical lesions were enrolled. Blood samples were tested for immunology, stool swabs and vaginal secretions were collected for microecological evaluation. At the same time, 21 kinds of common HPV virus types, cervical exfoliative cytology and 10 kinds of common STDs pathogens were detected. The included population will be tested with the same samples at 6, 12 and 24 months of follow-up to explore the relationship between vaginal, intestinal microorganisms and cervical HPV infection and the development of cervical lesions and its potential impact, so as to further explore the key factors affecting the persistent infection and clearance of HPV in female reproductive tract and the potential impact factors of the occurrence and development of cervical lesions. This prospective observational the characteristics of vaginal and intestinal microbiota in women with different cervical HPV infection, to evaluate the relationship and the underlying effect in the developoing of cervical lessions.
- Conditions
- Intestinal Microbiota, Vaginal Microbiota, HPV Infection
- Being tested
- Follow up
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
Participants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells.
| Study group | Role | What they receive |
|---|---|---|
| Women with cervical cytology (TCT) abnormalities | In the enrollment, women who have undergone cervical cytology (TCT) examination for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months, 12 months and 24 months. Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical histopathology testing at baseline
Cervical histopathology was performed at baseline for all participants.
Measured: Baseline
Cervical histopathology testing at 12-month follow-up
Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.
Measured: 12-month follow-up
Cervical histopathology testing at 24-month follow-up
Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.
Measured: 24-month follow-up
Human Papillomavirus (HPV) DNA testing at baseline
All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.
Measured: baseline
Human Papillomavirus (HPV) DNA testing at 6-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 6-month follow-up.
Measured: 6-month follow-up
Human Papillomavirus (HPV) DNA testing at 12-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 12-month follow-up.
Measured: 12-month follow-up
Human Papillomavirus (HPV) DNA testing at 24-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 24-month follow-up.
Measured: 24-month follow-up
Cervical cytology testing at baseline
All participants were tested for cervical cytology at the time of baseline.
Measured: baseline
Sequencing of the vaginal microbiota at baseline
All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.
Measured: baseline
Sequencing of the vaginal microbiota at 6-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 6-month follow-up.
Measured: 6-month follow-up
Sequencing of the vaginal microbiota at 12-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 12-month follow-up.
Measured: 12-month follow-up
Sequencing of the vaginal microbiota at 24-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 24-month follow-up.
Measured: 24-month follow-up
Sequencing of the gut microbiota at baseline
All participants underwent fecal microbiome sequencing at baseline.
Measured: baseline
Sequencing of the gut microbiota at 6-month follow-up
All participants underwent fecal microbiome sequencing at 6-month follow-up.
Measured: 6-month follow-up
Sequencing of the gut microbiota at 12-month follow-up
All participants underwent fecal microbiome sequencing at 12-month follow-up.
Measured: 12-month follow-up
Untargeted Metabolites of vaginal secretions testing at baseline
All participants were tested for microbial untargeted metabolites of vaginal secretions at baseline by liquid chromatography tandem mass spectrometric (LC-MS). Measure abundances of vaginal secretions metabolites, metabolic networks, and metabolic pathways activity.
Measured: baseline
Change in vaginal secretions metabolome from baseline to 12-month follow-up assessments
All participants were tested for microbial metabolites of vaginal secretions at 6-month follow-up and 12-month follow-up by LC-MS. Change in vaginal secretions metabolome from baseline to 12-month follow-up were assessed.
Measured: 6-month follow-up and 12-month follow-up
Serum metabolites testing at baseline
All participants were tested for serum metabolites at enrollment by LC-MS. Measure abundances of serum metabolites, metabolic networks, and metabolic pathways activity.
Measured: baseline
Change in serum metabolome from baseline to 12-month follow-up assessments
All participants were tested for microbial metabolites of serum at 6-month follow-up and 12-month follow-up by LC-MS. Change in serum metabolome from baseline to 12-month follow-up were assessed.
Measured: 6-month follow-up and 12-month follow-up
Secondary outcomes (4)
vaginal cytokine testing at enrollment
All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at enrollment.
Measured: Enrollment
vaginal cytokine testing at 6-month follow-up
All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 6-month follow-up.
Measured: 6-month follow-up
vaginal cytokine testing at 12-month follow-up
All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 12-month follow-up.
Measured: 12-month follow-up
vaginal cytokine testing at 24-month follow-up
All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 24-month follow-up.
Measured: 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jul 2021
- Primary completion31 Aug 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal MicrobiotaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 651 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binhua Dong, Fujian Maternity and Child Health Hospital
- Investigators
- Pengming Sun, PhD., Study chair, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003505
- Sponsor's protocol ID
- CVMC2018
- Status last verified
- Sep 2024
- First submitted
- 12 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection
- ClinicalTrials.gov ID
- NCT05003505
- Acronym / sponsor ID
- CVMC2018
- Conditions
- Intestinal Microbiota, Vaginal Microbiota, HPV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Aug 2021 (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.
There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.
Detailed description
Based on the clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, five research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University and Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University were included, each of which included 600 individuals, with a total of 3000 women with potential cervical lesions were enrolled. Blood samples were tested for immunology, stool swabs and vaginal secretions were collected for microecological evaluation. At the same time, 21 kinds of common HPV virus types, cervical exfoliative cytology and 10 kinds of common STDs pathogens were detected. The included population will be tested with the same samples at 6, 12 and 24 months of follow-up to explore the relationship between vaginal, intestinal microorganisms and cervical HPV infection and the development of cervical lesions and its potential impact, so as to further explore the key factors affecting the persistent infection and clearance of HPV in female reproductive tract and the potential impact factors of the occurrence and development of cervical lesions. This prospective observational the characteristics of vaginal and intestinal microbiota in women with different cervical HPV infection, to evaluate the relationship and the underlying effect in the developoing of cervical lessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with cervical cytology (TCT) abnormalities | – | Other: Follow upIn the enrollment, women who have undergone cervical cytology (TCT) examination for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months, 12 months and 24 months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese women aged 20-65 years with abnormal cervical cytology.
Key inclusion criteria (4 listed)
- Women aged 20-65.
- TCT examination was performed in the last 3 months with abnormal results.
- Non pregnant people with sexual history.
- Asexual life, no vaginal medication or flushing before 72 hours of sampling.
Key exclusion criteria (6 listed)
- Within 8 weeks after pregnancy or postpartum.
- Patients with history of genital tract tumor.
- History of HPV vaccination.
- Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
- In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow upParticipants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells. | Other | Women with cervical cytology (TCT) abnormalities |
Primary outcome
Cervical histopathology testing at baseline
Time frame: Baseline
Cervical histopathology was performed at baseline for all participants.
Cervical histopathology testing at 12-month follow-up
Time frame: 12-month follow-up
Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.
Cervical histopathology testing at 24-month follow-up
Time frame: 24-month follow-up
Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.
Human Papillomavirus (HPV) DNA testing at baseline
Time frame: baseline
All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.
Human Papillomavirus (HPV) DNA testing at 6-month follow-up
Time frame: 6-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 6-month follow-up.
Human Papillomavirus (HPV) DNA testing at 12-month follow-up
Time frame: 12-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 12-month follow-up.
Human Papillomavirus (HPV) DNA testing at 24-month follow-up
Time frame: 24-month follow-up
All participants were tested for HPV DNA of cervical exfoliated cells at the time of 24-month follow-up.
Cervical cytology testing at baseline
Time frame: baseline
All participants were tested for cervical cytology at the time of baseline.
Sequencing of the vaginal microbiota at baseline
Time frame: baseline
All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.
Sequencing of the vaginal microbiota at 6-month follow-up
Time frame: 6-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 6-month follow-up.
Sequencing of the vaginal microbiota at 12-month follow-up
Time frame: 12-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 12-month follow-up.
Sequencing of the vaginal microbiota at 24-month follow-up
Time frame: 24-month follow-up
All participants underwent microbiological metagenomic sequencing of vaginal secretions at 24-month follow-up.
Sequencing of the gut microbiota at baseline
Time frame: baseline
All participants underwent fecal microbiome sequencing at baseline.
Sequencing of the gut microbiota at 6-month follow-up
Time frame: 6-month follow-up
All participants underwent fecal microbiome sequencing at 6-month follow-up.
Sequencing of the gut microbiota at 12-month follow-up
Time frame: 12-month follow-up
All participants underwent fecal microbiome sequencing at 12-month follow-up.
Untargeted Metabolites of vaginal secretions testing at baseline
Time frame: baseline
All participants were tested for microbial untargeted metabolites of vaginal secretions at baseline by liquid chromatography tandem mass spectrometric (LC-MS). Measure abundances of vaginal secretions metabolites, metabolic networks, and metabolic pathways activity.
Change in vaginal secretions metabolome from baseline to 12-month follow-up assessments
Time frame: 6-month follow-up and 12-month follow-up
All participants were tested for microbial metabolites of vaginal secretions at 6-month follow-up and 12-month follow-up by LC-MS. Change in vaginal secretions metabolome from baseline to 12-month follow-up were assessed.
Serum metabolites testing at baseline
Time frame: baseline
All participants were tested for serum metabolites at enrollment by LC-MS. Measure abundances of serum metabolites, metabolic networks, and metabolic pathways activity.
Change in serum metabolome from baseline to 12-month follow-up assessments
Time frame: 6-month follow-up and 12-month follow-up
All participants were tested for microbial metabolites of serum at 6-month follow-up and 12-month follow-up by LC-MS. Change in serum metabolome from baseline to 12-month follow-up were assessed.
4 secondary outcomes
vaginal cytokine testing at enrollment
Time frame: Enrollment
vaginal cytokine testing at 6-month follow-up
Time frame: 6-month follow-up
vaginal cytokine testing at 12-month follow-up
Time frame: 12-month follow-up
vaginal cytokine testing at 24-month follow-up
Time frame: 24-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Pengming Sun, PhD. study chair
Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Microbiota and Vaginal Microbiota, run by Fujian Maternity and Child Health Hospital at 8 sites in China.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
Results are not available in the source record.
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?
Cervical histopathology testing at baseline (time frame: Baseline). The study lists 19 primary outcomes in all. 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 19 Sep 2024.