Study of the Vaginal Microbiota in Women Under Fertile Age

Completed

• Conditions: Vaginal Disease
• Interventions: Other: No intervention; Dietary Supplement: Probiotics

• Registration Number: NCT05817292
• Lead Sponsor: Universita degli Studi di Catania

Brief Summary

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 Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-05-29
• Study Completion: 2022-10-30
• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No intervention	No assumption of supplements containing probiotics
Probiotic	Probiotics	Assumption of commercially available supplements containing probiotics

Primary Outcome Measures

Name	Time	Method
Microbiota	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	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	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching

Secondary Outcome Measures

Name	Time	Method
Wellbeing	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	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.

Trial Locations

Locations (1)

University of Catania; 🇮🇹 Catania, Italy