Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03923985
Other study ID # SEID-Probiot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 21, 2019
Est. completion date October 30, 2019

Study information

Verified date February 2021
Source Instituto Palacios
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic containing Lactobacillus Crispatus
1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.

Locations

Country Name City State
Spain Instituto Palacios Madrid

Sponsors (1)

Lead Sponsor Collaborator
Instituto Palacios

Country where clinical trial is conducted

Spain, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06265740 - Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota N/A
Completed NCT00340275 - Longitudinal Study of Vaginal Flora N/A