Study of the Vaginal Microbiota in Women Under Fertile Age (vaginalbiota)

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

Study Overview

• Status: Completed
• Conditions: Vaginal Disease
• Intervention / Treatment: Dietary supplement: Probiotics; Other: No intervention

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95123
    • University of Catania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

healthy volunteers with vaginal microbiota imbalance

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Probiotic; Assumption of commercially available supplements containing probiotics	Dietary supplement: Probiotics; Assumption of commercial probiotics
Control; No assumption of supplements containing probiotics	Other: No intervention; No assumption of probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Symptomatology	Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)

Collaborators and Investigators

• Sponsor: Universita degli Studi di Catania
• Collaborators: ProBioEtna
• Investigators: Study Director: Antonio Cianci, Prof, University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): May 29, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases
• Other Study ID Numbers: 16/2022/PO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No