Baseline Study of Vaginal Microbiota in Healthy Chinses Female Population

NCT04887636 | Completed

• 1 other identifier: ZS-2902
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vagina Disease; Vaginal Community State Type

Keywords

Vaginal microbiota; Nugent score; Artificial intelligence; Next generation sequencing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (12)

• 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.

  PMID: 22746335 BACKGROUND

• 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.

  PMID: 28375652 BACKGROUND

• 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.

  PMID: 21757370 BACKGROUND

• 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.

  PMID: 20419168 BACKGROUND

• 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.

  PMID: 30036385 BACKGROUND

• 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.

  PMID: 18077845 BACKGROUND

• 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.

  PMID: 31413606 BACKGROUND

• 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.

  PMID: 20534435 BACKGROUND

• 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.

  PMID: 33228810 BACKGROUND

• 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.

  PMID: 25921792 BACKGROUND

• Tao Zhi, Liao Qinping. Research progress and clinical significance of vaginal microecology. Journal of Practical Obstetrics and Gynecology, 2018, 34(10):721-723.

  BACKGROUND

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lan Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: May 21, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)