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

Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03923985

Enrollment

Registered

2019-04-23

Start date

2019-03-21

Completion date

2019-10-30

Last updated

2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Flora

Keywords

Vaginal Flora, Oral Probiotics

Brief summary

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

Interventions

DIETARY_SUPPLEMENTProbiotic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in the number of Lactobacillus Crispatus on the vaginal flora	Screening, month 2	Analysis of vaginal lactobacilli.

Secondary

Measure	Time frame	Description
Changes in vaginal PH	Screening, month 2	PH measurement

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026