Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora
Not Applicable
Completed
- Conditions
- Vaginal Flora
- Interventions
- Dietary Supplement: Probiotic containing Lactobacillus Crispatus
- 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
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
- Arm && Interventions
Group Intervention Description Active Arm Probiotic containing Lactobacillus Crispatus 1 tablet / day of probiotic containing 10 Mld L. crispatus during two months
- 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