Vaginal DiseasevaginalbiotaNCT05817292
Study of the Vaginal Microbiota in Women Under Fertile Age
An observational study of Vaginal Disease, run by University of Catania at 1 site in Italy.
Trial summary
Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Disease
- What is being tested?
- Probiotics
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 30 Oct 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers with vaginal microbiota imbalance
Who may be able to join
- Age between 18 and 45 years;
- Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);
- Presence of at least 3 Amsel criteria;
- Nugent score ≥ 7;
- lactobacillary grade ≥ 2 (LBG) (according to Donders classification);
- presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy
Who cannot join
- Age < 18 years;
- Nugent score < 7;
- presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
- Clinically apparent herpes simplex infection;
- Human papillomavirus or human immunodeficiency virus infections;
- Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks;
- Use of vaginal contraceptives;
- Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.
Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders
Read the detailed description
The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders
- Conditions
- Vaginal Disease
- Being tested
- Probiotics, No intervention
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Assumption of commercial probiotics
No interventionOther
No assumption of probiotics
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Assumption of commercially available supplements containing probiotics Receives: Dietary Supplement: Probiotics | |
| Control | No assumption of supplements containing probiotics Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota
Change from baseline in the composition of the vaginal microbiota with the increase of the cell density of lactobacilli (at least 3 log units) and decrease of pathogens (at least 2 log units) at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Measured: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Signs
Change from baseline of Amsel's criteria at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Measured: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Signs
Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Measured: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Symptomatology
Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching
Measured: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Secondary outcomes (1)
Wellbeing
Change from baseline of the quality of life based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.
Measured: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Feb 2022
- Primary completion29 May 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Collaborators
- ProBioEtna
- Responsible party
- Principal investigator, Agnese Maria Chiara Rapisarda, University of Catania
- Investigators
- Antonio Cianci, Prof, Study director, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817292
- Sponsor's protocol ID
- 16/2022/PO
- Acronym
- vaginalbiota
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.
- ClinicalTrials.gov ID
- NCT05817292
- Acronym / sponsor ID
- vaginalbiota / 16/2022/PO
- Conditions
- Vaginal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- ProBioEtna
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 18 Apr 2023 (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.
Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders
Detailed description
The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | – | Dietary Supplement: ProbioticsAssumption of commercially available supplements containing probiotics |
| Control | – | Other: No interventionNo assumption of supplements containing probiotics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers with vaginal microbiota imbalance
Key inclusion criteria (6 listed)
- Age between 18 and 45 years;
- Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);
- Presence of at least 3 Amsel criteria;
- Nugent score ≥ 7;
- lactobacillary grade ≥ 2 (LBG) (according to Donders classification);
Key exclusion criteria (8 listed)
- Age < 18 years;
- Nugent score < 7;
- presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
- Clinically apparent herpes simplex infection;
- Human papillomavirus or human immunodeficiency virus infections;
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 |
|---|---|---|
| ProbioticsAssumption of commercial probiotics | Dietary supplement | Probiotic |
| No interventionNo assumption of probiotics | Other | Control |
Primary outcome
Microbiota
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline in the composition of the vaginal microbiota with the increase of the cell density of lactobacilli (at least 3 log units) and decrease of pathogens (at least 2 log units) at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Signs
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline of Amsel's criteria at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Signs
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Symptomatology
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching
1 secondary outcome
Wellbeing
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
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 18 Apr 2023.
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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.
Antonio Cianci, Prof study director
University of Catania
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 Vaginal Disease, run by University of Catania at 1 site in Italy.
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 6 inclusion and 8 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 18 Apr 2023. 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 Italy. 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?
Microbiota (time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)). The study lists 4 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 18 Apr 2023.