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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923985
• Other study ID #: SEID-Probiot
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Vaginal Flora

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