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

Instituto Palacios

Status: Completed

Conditions: Vaginal Flora

Treatments: Dietary Supplement: Probiotic containing Lactobacillus Crispatus

Study type: Interventional

Funder types: Other

Identifiers

NCT03923985

SEID-Probiot

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Active Arm

Active Comparator group

Description:

1 tablet / day of probiotic containing 10 Mld L. crispatus during two months

Treatment:

Dietary Supplement: Probiotic containing Lactobacillus Crispatus

Control Arm

No Intervention group

Description:

No treatment