Study of the Vaginal Microbiota in Women Under Fertile Age

NCT05817292 | Completed

• 1 other identifier: 16/2022/PO
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaginal Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Wellbeing

  Baseline; end of the treatment (10 days) ; wash-out (4 weeks)

Study Arms (2)

Probiotic

Assumption of commercially available supplements containing probiotics

Dietary Supplement: Probiotics

Control

No assumption of supplements containing probiotics

Other: No intervention

Interventions

Probiotics DIETARY_SUPPLEMENT

Assumption of commercial probiotics

Probiotic

No intervention OTHER

No assumption of probiotics

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women in fertile age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy volunteers with vaginal microbiota imbalance

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universita degli Studi di Catania: lead
• ProBioEtna: collaborator

Study Sites (1)

University of Catania

Catania, 95123, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

vaginal discharge

MeSH Terms

Conditions

Vaginal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Antonio Cianci, Prof

  University of Catania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: February 1, 2022
• Primary Completion: May 29, 2022
• Study Completion: October 30, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

IT (1)