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

February 10, 2021 updated by: Instituto Palacios

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Instituto Palacios

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Arm
1 tablet / day of probiotic containing 10 Mld L. crispatus during two months
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.
No Intervention: Control Arm
No treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in vaginal PH
Time Frame: Screening, month 2
PH measurement
Screening, month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Palacios

Investigators

  • Principal Investigator: Santiago Palacios, PhD, Instituto Palacios

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEID-Probiot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginal Flora

Clinical Trials on Probiotic containing Lactobacillus Crispatus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe