Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora

Not Applicable

Completed

• Conditions: Vaginal Flora

• Registration Number: NCT03923985
• Lead Sponsor: Instituto Palacios

Brief Summary

Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-23
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Healthy women between 18 and 45 years old
• Women without current symptoms of vaginal infection
• Negative bacteriological and clinical examination

Exclusion Criteria

• Women with vaginal infection
• Women with undiagnosed vaginal bleeding
• Patients with endometrial hyperplasia
• Suspicion of neoplasia or active neoplasia
• Women with intolerance, allergy or hypersensitivity to the components of the probiotic
• Women with immunosuppressive disorders or with HIV
• Women who are currently using probiotics by any route of administration
• Women who are using some treatment for vaginal sepsis
• Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
• Pregnant women or those with precocious menopause

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in the number of Lactobacillus Crispatus on the vaginal flora	Screening, month 2	Analysis of vaginal lactobacilli.

Secondary Outcome Measures

Name	Time	Method
Changes in vaginal PH	Screening, month 2	PH measurement

Trial Locations

Locations (1)

Instituto Palacios; 🇪🇸 Madrid, Spain