Vagina DiseaseBSOVMNCT04887636
Baseline Study of Vaginal Microbiota in Healthy Chinses Female Population
An observational study of Vagina Disease and Vaginal Community State Type, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The reproductive tract microecology is an important part of the human microbial system. Microorganisms and the host reproductive tract environment form a stable symbiotic relationship. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vagina Disease, Vaginal Community State Type
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2021to 15 Jul 2022
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.
Who may be able to join
- Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old;
- Women who are evaluated as normal by vaginal microbiome morphological characterization;
- Women who agree to participate in this study and have signed an informed consent form;
- Those who have full capacity for civil and legal conduct;
- The quality of vaginal samples meets the evaluation requirements of this program.
Who cannot join
- The sampling quality of vaginal secretions does not meet the research study requirements;
- The quality or format of the slide collection of vaginal smears does not meet the requirements;
- Women with severe physical or mental illness;
- Users of hormone therapy and antibiotic drugs;
- Women with insufficient compliance with this study;
- Women who are participating in other coinciding clinical drug or medical device trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
The reproductive tract microecology is an important part of the human microbial system. Microorganisms and the host reproductive tract environment form a stable symbiotic relationship. When pathogens invade or microecology imbalance，it can lead to serious reproductive tract infection.Reproductive tract infection is one of the most common disease among women，and it is a global social and public health problem. Reproductive tract infection is characterized by high morbidity, low cure rate and high recurrence rate.Data from the studies shows that 40% of Chinese women suffer from reproductive tract infections of varying degrees, that is, at least 200 million. Long-term chronic infections can lead to serious consequences such as infertility, tumor, abortion and premature birth. At present, the diagnostic classification of reproductive tract infection is mainly divided into Aerobic vaginitis（AV), Bacterial vaginosis（BV), Vulvovaginal candidiasis（VVC) and Trichomonas vaginitis（TV). The reproductive tract microbiota is complex, but the clinical classification is relatively simple, which makes the treatment lack of precision. More precise treatment，permanent cure and reducing the recurrence rate are the top priorities in the field of medical and health.
Read the detailed description
At present, the treatment of vaginitis is dominated by anti-pathogen medicine. While killing pathogenic microorganisms, it also inhibits the growth of normal vaginal lactobacillus, which further aggravates the vaginal microecological imbalance and makes it the root of refractory, drug-resistant and recurrent reproductive tract infections.
A growing number of studies show that the key point of the treatment for reproductive tract infections is to adjust the proportion of vaginal microorganism composition, in order to achieve the initial Lactobacillus dominant state, and maintaining the balance of vaginal microecology .
The composition and proportion of microorganisms in the lower reproductive tract influenced by a variety of factors, such as changes in sex hormone levels and phases of the menstrual cycle, sexual activity, antibiotic treatment and use of oral contraceptives, vaginal irrigation, menopause, pregnancy, breastfeeding, diabetes and stress . Also, there are obvious differences between different ethnicities and regions . Therefore, we need to conduct correlation analysis on the microbiota structure and various indicators of the Chinese population, and develop a more reasonable method for classifying lower reproductive tract infections and treatments. According to this classification method, accurate diagnosis of vaginal disease is further carried out, more rational treatment options can be implemented，and the health of patients is effectively improved.
Based on the above background, the study collected DNA from vaginal secretions from about 10,000 healthy Chinese women of reproductive age. And the DNA was tested by next genetic sequencing.The data obtained in this project will establish the baseline of the lower reproductive tract microbiome of Chinese population, and will be used for future research and comparison. The results will be used to explore the comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.
- Conditions
- Vagina Disease, Vaginal Community State Type
- Keywords
- Vaginal microbiota, Nugent score, Artificial intelligence, Next generation sequencing
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Normal women group | I. Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old; II. Women who are evaluated as normal by vaginal microbiome morphological characterization; III. Women who agree to participate in this study and have signed an informed consent form; IV. Those who have full capacity for civil and legal conduct; V. The quality of vaginal samples meets the evaluation requirements of this program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nugent score
The morphological manifestations of vaginal microflora were observed by the examiner under the microscope, and the vaginal microecological results were evaluated according to the Nugent score.Nugent Scoring System（0-10）for Gram-Stained Vaginal Smears Total Score：0-3 Normal； 4-6 Intermediate；7-10 Bacterial Vaginosis
Measured: 1 year
Next generation sequencing
16s rRNA gene sequencing and metagenomic sequencing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start21 May 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vagina DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887636
- Sponsor's protocol ID
- ZS-2902
- Acronym
- BSOVM
- Status last verified
- Apr 2024
- First submitted
- 11 May 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma B, Forney LJ, Ravel J. Vaginal microbiome: rethinking health and disease. Annu Rev Microbiol. 2012;66:371-89. doi: 10.1146/annurev-micro-092611-150157. Epub 2012 Jun 28.
PubMed 22746335Knight R, Callewaert C, Marotz C, Hyde ER, Debelius JW, McDonald D, Sogin ML. The Microbiome and Human Biology. Annu Rev Genomics Hum Genet. 2017 Aug 31;18:65-86. doi: 10.1146/annurev-genom-083115-022438. Epub 2017 Mar 20.
PubMed 28375652White BA, Creedon DJ, Nelson KE, Wilson BA. The vaginal microbiome in health and disease. Trends Endocrinol Metab. 2011 Oct;22(10):389-93. doi: 10.1016/j.tem.2011.06.001. Epub 2011 Jul 13.
PubMed 21757370Srinivasan S, Liu C, Mitchell CM, Fiedler TL, Thomas KK, Agnew KJ, Marrazzo JM, Fredricks DN. Temporal variability of human vaginal bacteria and relationship with bacterial vaginosis. PLoS One. 2010 Apr 15;5(4):e10197. doi: 10.1371/journal.pone.0010197.
PubMed 20419168Crucitti T, Hardy L, van de Wijgert J, Agaba S, Buyze J, Kestelyn E, Delvaux T, Mwambarangwe L, De Baetselier I, Jespers V; Ring Plus study group. Contraceptive rings promote vaginal lactobacilli in a high bacterial vaginosis prevalence population: A randomised, open-label longitudinal study in Rwandan women. PLoS One. 2018 Jul 23;13(7):e0201003. doi: 10.1371/journal.pone.0201003. eCollection 2018.
PubMed 30036385Riggs M, Klebanoff M, Nansel T, Zhang J, Schwebke J, Andrews W. Longitudinal association between hormonal contraceptives and bacterial vaginosis in women of reproductive age. Sex Transm Dis. 2007 Dec;34(12):954-9.
PubMed 18077845Sobel JD, Kaur N, Woznicki NA, Boikov D, Aguin T, Gill G, Akins RA. Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. Infect Drug Resist. 2019 Jul 24;12:2297-2307. doi: 10.2147/IDR.S213853. eCollection 2019.
PubMed 31413606Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.
PubMed 20534435France MT, Ma B, Gajer P, Brown S, Humphrys MS, Holm JB, Waetjen LE, Brotman RM, Ravel J. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome. 2020 Nov 23;8(1):166. doi: 10.1186/s40168-020-00934-6.
PubMed 33228810Mizock BA. Probiotics. Dis Mon. 2015 Jul;61(7):259-90. doi: 10.1016/j.disamonth.2015.03.011. Epub 2015 Apr 25. No abstract available.
PubMed 25921792Tao Zhi, Liao Qinping. Research progress and clinical significance of vaginal microecology. Journal of Practical Obstetrics and Gynecology, 2018, 34(10):721-723.
Qin-ping Liao, Dai Zhang. Current status and research progress of diagnosis and treatment of female reproductive tract infections in China. International Journal of Obstetrics and Gynecology, 2011(06):8-10
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Study of Vaginal Microbiota in Healthy Chinses Female Population
- ClinicalTrials.gov ID
- NCT04887636
- Acronym / sponsor ID
- BSOVM / ZS-2902
- Conditions
- Vagina Disease, Vaginal Community State Type
- Keywords
- Vaginal microbiota, Nugent score, Artificial intelligence, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 21 May 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 14 May 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.
The reproductive tract microecology is an important part of the human microbial system. Microorganisms and the host reproductive tract environment form a stable symbiotic relationship. When pathogens invade or microecology imbalance，it can lead to serious reproductive tract infection.Reproductive tract infection is one of the most common disease among women，and it is a global social and public health problem. Reproductive tract infection is characterized by high morbidity, low cure rate and high recurrence rate.Data from the studies shows that 40% of Chinese women suffer from reproductive tract infections of varying degrees, that is, at least 200 million. Long-term chronic infections can lead to serious consequences such as infertility, tumor, abortion and premature birth. At present, the diagnostic classification of reproductive tract infection is mainly divided into Aerobic vaginitis（AV), Bacterial vaginosis（BV), Vulvovaginal candidiasis（VVC) and Trichomonas vaginitis（TV). The reproductive tract microbiota is complex, but the clinical classification is relatively simple, which makes the treatment lack of precision. More precise treatment，permanent cure and reducing the recurrence rate are the top priorities in the field of medical and health.
Detailed description
At present, the treatment of vaginitis is dominated by anti-pathogen medicine. While killing pathogenic microorganisms, it also inhibits the growth of normal vaginal lactobacillus, which further aggravates the vaginal microecological imbalance and makes it the root of refractory, drug-resistant and recurrent reproductive tract infections.
A growing number of studies show that the key point of the treatment for reproductive tract infections is to adjust the proportion of vaginal microorganism composition, in order to achieve the initial Lactobacillus dominant state, and maintaining the balance of vaginal microecology .
The composition and proportion of microorganisms in the lower reproductive tract influenced by a variety of factors, such as changes in sex hormone levels and phases of the menstrual cycle, sexual activity, antibiotic treatment and use of oral contraceptives, vaginal irrigation, menopause, pregnancy, breastfeeding, diabetes and stress . Also, there are obvious differences between different ethnicities and regions . Therefore, we need to conduct correlation analysis on the microbiota structure and various indicators of the Chinese population, and develop a more reasonable method for classifying lower reproductive tract infections and treatments. According to this classification method, accurate diagnosis of vaginal disease is further carried out, more rational treatment options can be implemented，and the health of patients is effectively improved.
Based on the above background, the study collected DNA from vaginal secretions from about 10,000 healthy Chinese women of reproductive age. And the DNA was tested by next genetic sequencing.The data obtained in this project will establish the baseline of the lower reproductive tract microbiome of Chinese population, and will be used for future research and comparison. The results will be used to explore the comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal women group | – | –I. Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old; II. Women who are evaluated as normal by vaginal microbiome morphological characterization; III. Women who agree to participate in this study and have signed an informed consent form; IV. Those who have full capacity for civil and legal conduct; V. The quality of vaginal samples meets the evaluation requirements of this program. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.
Key inclusion criteria (5 listed)
- Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old;
- Women who are evaluated as normal by vaginal microbiome morphological characterization;
- Women who agree to participate in this study and have signed an informed consent form;
- Those who have full capacity for civil and legal conduct;
- The quality of vaginal samples meets the evaluation requirements of this program.
Key exclusion criteria (6 listed)
- The sampling quality of vaginal secretions does not meet the research study requirements;
- The quality or format of the slide collection of vaginal smears does not meet the requirements;
- Women with severe physical or mental illness;
- Users of hormone therapy and antibiotic drugs;
- Women with insufficient compliance with this study;
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 |
|---|---|---|
| Other | Normal women group |
Primary outcome
Nugent score
Time frame: 1 year
The morphological manifestations of vaginal microflora were observed by the examiner under the microscope, and the vaginal microecological results were evaluated according to the Nugent score.Nugent Scoring System（0-10）for Gram-Stained Vaginal Smears Total Score：0-3 Normal； 4-6 Intermediate；7-10 Bacterial Vaginosis
Next generation sequencing
Time frame: 1 year
16s rRNA gene sequencing and metagenomic sequencing
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 11 Apr 2024.
- Background: PubMed 22746335Ma B, Forney LJ, Ravel J. Vaginal microbiome: rethinking health and disease. Annu Rev Microbiol. 2012;66:371-89. doi: 10.1146/annurev-micro-092611-150157. Epub 2012 Jun 28.
- Background: PubMed 28375652Knight R, Callewaert C, Marotz C, Hyde ER, Debelius JW, McDonald D, Sogin ML. The Microbiome and Human Biology. Annu Rev Genomics Hum Genet. 2017 Aug 31;18:65-86. doi: 10.1146/annurev-genom-083115-022438. Epub 2017 Mar 20.
- Background: PubMed 21757370White BA, Creedon DJ, Nelson KE, Wilson BA. The vaginal microbiome in health and disease. Trends Endocrinol Metab. 2011 Oct;22(10):389-93. doi: 10.1016/j.tem.2011.06.001. Epub 2011 Jul 13.
- Background: PubMed 20419168Srinivasan S, Liu C, Mitchell CM, Fiedler TL, Thomas KK, Agnew KJ, Marrazzo JM, Fredricks DN. Temporal variability of human vaginal bacteria and relationship with bacterial vaginosis. PLoS One. 2010 Apr 15;5(4):e10197. doi: 10.1371/journal.pone.0010197.
- Background: PubMed 30036385Crucitti T, Hardy L, van de Wijgert J, Agaba S, Buyze J, Kestelyn E, Delvaux T, Mwambarangwe L, De Baetselier I, Jespers V; Ring Plus study group. Contraceptive rings promote vaginal lactobacilli in a high bacterial vaginosis prevalence population: A randomised, open-label longitudinal study in Rwandan women. PLoS One. 2018 Jul 23;13(7):e0201003. doi: 10.1371/journal.pone.0201003. eCollection 2018.
- Background: PubMed 18077845Riggs M, Klebanoff M, Nansel T, Zhang J, Schwebke J, Andrews W. Longitudinal association between hormonal contraceptives and bacterial vaginosis in women of reproductive age. Sex Transm Dis. 2007 Dec;34(12):954-9.
- Background: PubMed 31413606Sobel JD, Kaur N, Woznicki NA, Boikov D, Aguin T, Gill G, Akins RA. Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses. Infect Drug Resist. 2019 Jul 24;12:2297-2307. doi: 10.2147/IDR.S213853. eCollection 2019.
- Background: PubMed 20534435Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.
- Background: PubMed 33228810France MT, Ma B, Gajer P, Brown S, Humphrys MS, Holm JB, Waetjen LE, Brotman RM, Ravel J. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome. 2020 Nov 23;8(1):166. doi: 10.1186/s40168-020-00934-6.
- Background: PubMed 25921792Mizock BA. Probiotics. Dis Mon. 2015 Jul;61(7):259-90. doi: 10.1016/j.disamonth.2015.03.011. Epub 2015 Apr 25. No abstract available.
- BackgroundTao Zhi, Liao Qinping. Research progress and clinical significance of vaginal microecology. Journal of Practical Obstetrics and Gynecology, 2018, 34(10):721-723.
- BackgroundQin-ping Liao, Dai Zhang. Current status and research progress of diagnosis and treatment of female reproductive tract infections in China. International Journal of Obstetrics and Gynecology, 2011(06):8-10
- Individual participant dataSharing planned: Undecided
Related trials for Vagina Disease
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
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.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
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 Vagina Disease and Vaginal Community State Type, run by Peking Union Medical College Hospital at 1 site 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 5 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: finished, as of the sponsor's last update on 11 Apr 2024. 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 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?
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?
Nugent score (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887636, which also lists 12 linked publications.
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 11 Apr 2024.