NCT03923985

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

April 5, 2019

Last Update Submit

February 10, 2021

Conditions

Vaginal Flora

Keywords

Vaginal FloraOral Probiotics

Outcome Measures

Primary Outcomes (1)

  • Changes in the number of Lactobacillus Crispatus on the vaginal flora

    Analysis of vaginal lactobacilli.

    Screening, month 2

Secondary Outcomes (1)

  • Changes in vaginal PH

    Screening, month 2

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic containing Lactobacillus Crispatus

Control Arm

NO INTERVENTION

No treatment

Interventions

Probiotic containing Lactobacillus CrispatusDIETARY_SUPPLEMENT

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.

Active Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly Females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women between 18 and 45 years old
  • Women without current symptoms of vaginal infection
  • Negative bacteriological and clinical examination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

Study Officials

  • Santiago Palacios, PhD

    Instituto Palacios

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 23, 2019

Study Start

March 21, 2019

Primary Completion

September 30, 2019

Study Completion

October 30, 2019

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

ES(1)