VaginitisESSACWVMNCT02763696
Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota
An observational study of Vaginitis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. Undermining the balance of the vagina is closely related to infectious diseases and tumors. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginitis
- What is being tested?
- Composition of Viginal flora of Child-Bearing women
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2016to Dec 2018
- How long will I take part?
- 1 Month
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Child-bearing Woman
Who may be able to join
- Normal Child-bearing Women
Who cannot join
- Pregnancy women
- Lactating women
- Using antibiotics or vaginal topical application of antibiotics over a month
- Have sexual activity in 3 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Yawen Wang, Ph.D, 008613259935869, wanglxy628@sina.com
About this study
Official title: Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota Which Overall Evaluation of Microscopic Precision Reference Standards
The vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. Undermining the balance of the vagina is closely related to infectious diseases and tumors.
The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species, including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .
Read more
Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on microscopy and conventional culture method to obtain vaginal microflora information have a variety of deviation. For this reason, The in-depth study of complex vaginal flora and the correct understanding of disease faces a serious obstacle. With the development of High-throughput sequencing technology， metagenomics can get all the composition and distribution of microorganisms from the sample which traditional knowledge may not be with microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic criteria for clinical diagnosis of the disease is necessary.
In this study, the investigators use high-throughput sequencing technology to detect women of childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi, viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the investigators want to re-cognition the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.
- Conditions
- Vaginitis
- Being tested
- Composition of Viginal flora of Child-Bearing women
- Keywords
- Metagenomics, Vaginal microflora, High-throughput sequencing
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composition of Viginal flora of Child-Bearing womenOther
Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis
| Study group | Role | What they receive |
|---|---|---|
| normal women | Composition of Viginal flora of Child-Bearing women in normal woman Receives: Other: Composition of Viginal flora of Child-Bearing women | |
| vaginitis women | Women of childbearing age with vaginitis Receives: Other: Composition of Viginal flora of Child-Bearing women |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing Women
Measured: From the date of first normal woman who entered the subject to a whole menstrual cycles ended up to one month
The use of High-throughput sequencing to comparison the composition of vaginal flora of normal women of childbearing age and women with vaginitis
Measured: From the date of one subjects entered to a whole menstrual cycles ended up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start10 May 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yawen Wang, Ph.D, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763696
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-009
- Acronym
- ESSACWVM
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2016
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota Which Overall Evaluation of Microscopic Precision Reference Standards
- ClinicalTrials.gov ID
- NCT02763696
- Acronym / sponsor ID
- ESSACWVM / XJTU1AF-CRF-2015-009
- Conditions
- Vaginitis
- Keywords
- Metagenomics, Vaginal microflora, High-throughput sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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 vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. Undermining the balance of the vagina is closely related to infectious diseases and tumors.
The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species, including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .
Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on microscopy and conventional culture method to obtain vaginal microflora information have a variety of deviation. For this reason, The in-depth study of complex vaginal flora and the correct understanding of disease faces a serious obstacle. With the development of High-throughput sequencing technology， metagenomics can get all the composition and distribution of microorganisms from the sample which traditional knowledge may not be with microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic criteria for clinical diagnosis of the disease is necessary.
In this study, the investigators use high-throughput sequencing technology to detect women of childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi, viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the investigators want to re-cognition the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal women | – | Other: Composition of Viginal flora of Child-Bearing womenComposition of Viginal flora of Child-Bearing women in normal woman |
| vaginitis women | – | Other: Composition of Viginal flora of Child-Bearing womenWomen of childbearing age with vaginitis |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Child-bearing Woman
Key inclusion criteria (1 listed)
- Normal Child-bearing Women
Key exclusion criteria (4 listed)
- Pregnancy women
- Lactating women
- Using antibiotics or vaginal topical application of antibiotics over a month
- Have sexual activity in 3 days
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 |
|---|---|---|
| Composition of Viginal flora of Child-Bearing womenUse high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis | Other | normal women, vaginitis women |
Primary outcome
The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing Women
Time frame: From the date of first normal woman who entered the subject to a whole menstrual cycles ended up to one month
The use of High-throughput sequencing to comparison the composition of vaginal flora of normal women of childbearing age and women with vaginitis
Time frame: From the date of one subjects entered to a whole menstrual cycles ended up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Vaginitis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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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.
Yawen Wang, Ph.D study chair
First Affiliated Hospital of Xian Jiaotong University
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 Vaginitis, run by First Affiliated Hospital Xi'an Jiaotong University 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 1 inclusion and 4 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 24 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yawen Wang, Ph.D (008613259935869, wanglxy628@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing Women (time frame: From the date of first normal woman who entered the subject to a whole menstrual cycles ended up to one month). 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?
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 24 Mar 2017.