CTRI/2020/02/023350Not yet recruitingNot Applicable
Studies on the Pre-biotic and biological activities of ingredients/formulationsfor improving vaginal health - in vitro study
Cavinkare Pvt Ltd1 site in 1 country6 target enrollmentStarted: February 3, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Understanding the growth kinetics of Lactobacillus for vaginal health improvement
Study Overview
Brief Summary
The vaginal clinical swab will be collected from hospital post swabbing by the clinicians. The swabs will transported and Lactobacilli will be isolated and characterized. Lactobacilli isolated from clinical swabs will be plated on the Vaginal epithelial cells line and allowed to adhere. These cells will be treated with ingredients/formulations to understand their ability to adhere to the cells in the presence and absence of the active ingredients.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female subjects aged between 18 to 3 5 years who are in active menstrual cycle with Informed Consent signed by subjects/patients for collection of vaginal clinical swabs for research purpose.
Exclusion Criteria
- •Feeding mothers/pregnant women Subjects suffering from any clinically proven diseases/condition/any infective or contagious diseases.
- •Subjects who are under antibiotic treatment for past 15 days.
Outcomes
Primary Outcomes
Understanding the growth kinetics of Lactobacillus for vaginal health improvement
Time Frame: Day 1 sample collection and processing experiments | Day 10 sample analysis
Secondary Outcomes
- Development of better formultions for vaginal health(Day 1 sample collection and processing experiments)
Investigators
Study Sites (1)
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