Vaginal Flora Clinical Trial
Official title:
Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
Verified date | February 2021 |
Source | Instituto Palacios |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora
Status | Completed |
Enrollment | 40 |
Est. completion date | October 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Palacios | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto Palacios |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the number of Lactobacillus Crispatus on the vaginal flora | Analysis of vaginal lactobacilli. | Screening, month 2 | |
Secondary | Changes in vaginal PH | PH measurement | Screening, month 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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