NCT04887636|Completed
Baseline Study of Vaginal Microbiota in Healthy Chinses Female Population
BSOVM
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BSOVM
Sponsor study identifier
observational
1,000
1 country
1
Study Start
May 21, 2021
Actual (reported)Primary Completion
July 15, 2022
Actual (reported)Study Completion
July 15, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2021
Actual (reported)May 14, 2021
Actual (reported)May 21, 2021
Actual (reported)July 15, 2022
Actual (reported)July 15, 2022
Actual (reported)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
1 year
Next generation sequencing
16s rRNA gene sequencing and metagenomic sequencing
1 year
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.
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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.
Knight 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.
The vaginal secretions were stained with Gram for morphological analysis. The metagenomics or 16s rRNA high-throughput sequencing combined with bioinformatics were used to calculate the structure of the vaginal microbiome flora of subjects.
Lan Zhu, MD
Peking Union Medical College Hospital
1,000 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2021
First Posted
May 14, 2021
Study Start
May 21, 2021
Actual (reported)Contact the study team to confirm eligibility.
White 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.
Srinivasan 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.
Crucitti 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.
Riggs 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.
Sobel 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.
Ravel 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.
France 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.
Mizock 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.
Tao 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
Primary Completion
July 15, 2022
Actual (reported)Study Completion
July 15, 2022
Actual (reported)Last Updated
April 11, 2024
Record last verified: 2024-04
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