Study of the Vaginal Microbiota in Women Under Fertile Age

Vaginal Disease Clinical Trial

— vaginalbiota  

Official title:

Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817292
• Other study ID #: 16/2022/PO
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: April 2023
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2022
• Est. primary completion date: May 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vaginal Disease
• Vaginal Diseases

Intervention

Dietary Supplement:
• Probiotics
Assumption of commercial probiotics

Other:
• No intervention
No assumption of probiotics

Locations

Country	Name	City	State
Italy	University of Catania	Catania

Sponsors (2)

Lead Sponsor	Collaborator
Universita degli Studi di Catania	ProBioEtna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)