Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers

July 19, 2023 updated by: AB Biotics, SA

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Vaginal Colonization Capacity, Safety, and Tolerability of Two New Strains of L. Gasseri and L. Crispatus When Administered Orally in Healthy Female Volunteers

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Double blind, randomized, placebo-controlled biomedical research study to determine whether supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will receive placebo, starting the day after menstruation is over. Main study outcome will be colonization throughout the study, which will be determined by analysis of specific strains by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal microbiota, vaginal pH and adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ana Maria Aldea Perona, PhD
  • Phone Number: 0034 93 3160490
  • Email: aaldea@imim.es

Study Locations

  • Spain
      • Barcelona, Spain
        • Instituto Hospital del Mar de Investigaciones Médicas

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy women
  • Reproductive age 18-45 years

Exclusion Criteria:

  • Vaginal infection or symptoms (AMSEL criteria).
  • Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)
  • Suffer from chronic diarrhea or constipation or short bowel syndrome,
  • Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.
  • Pregnant women or willing to be during the study, lactating women.
  • Having taken another probiotic during the month prior to study entry orally or vaginally. This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.
  • Intake of immunomodulators or systemic corticosteroids.
  • History of alcohol or drug abuse.
  • Menopausal women.
  • Use of the IUD.
  • Use of spermicides or vaginal lubricants during the month prior to study entry.
  • Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).
  • Have participated in a clinical trial during the month prior to entering the study.
  • Not being able to follow or understand study procedures. This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.
  • Any other condition not compatible with the study according to the investigators

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Maltodextrin (E1400, qs) oral capsule once a day
Dietary supplement: Placebo
One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over
Experimental: Experimental 1
L. gasseri oral capsule
Dietary supplement: Experimental 1
L. gasseri oral capsule once a day (1 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over
Other Names:
  • Probiotic
Experimental: Experimental 2
L. gasseri + L. crispatus oral capsule
Dietary supplement: Experimental 2
L. gasseri and L. crispatus oral capsule once a day (1.5 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over
Other Names:
  • Probiotic mixture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Colonization of L. crispatus strain in the vagina
Time Frame: 0,15 or 18 days
Change in the concentration of L. crispatus strain throughout study period measured by qPCR in samples obtained with vaginal swab
0,15 or 18 days
Colonization of L. gasseri strain in the vagina
Time Frame: 0,15 or 18 days
Change in the concentration of L. gasseri strain throughout study period measured by qPCR in samples obtained with vaginal swab
0,15 or 18 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vaginal microbiota composition
Time Frame: Day 0, 6, 12 and 15 or 18
Change in vaginal microbiota composition measured by 16S rRNA sequencing analysis in samples obtained from vaginal swabs
Day 0, 6, 12 and 15 or 18
Vaginal pH
Time Frame: Day 0, 3, 6, 9, 12, 15, 18
Change in vaginal pH throughout study period measured by pH test strip
Day 0, 3, 6, 9, 12, 15, 18
Adverse events
Time Frame: 18 days
Frequency of adverse events throughout study period
18 days
Satisfaction with the product
Time Frame: Day 18
Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM)
Day 18
Vaginal colonization of L. gasseri strain
Time Frame: Day 0, 3, 6, 9, 12, 15
Change in the vaginal concentration of L. gasseri strain measured by qPCR versus baseline
Day 0, 3, 6, 9, 12, 15
Vaginal colonization of L. crispatus strain
Time Frame: Day 0, 3, 6, 9, 12, 15
Change in the vaginal concentration of L. crispatus strain measured by qPCR versus baseline
Day 0, 3, 6, 9, 12, 15
Perianal concentration of L. crispatus strain
Time Frame: Day 0, 9 and 15 or 18
Change in the perianal concentration of L. crispatus strain measured by qPCR
Day 0, 9 and 15 or 18
Perianal concentration of L. gasseri strain
Time Frame: Day 0, 9 and 15 or 18
Change in the perianal concentration of L. gasseri strain measured by qPCR
Day 0, 9 and 15 or 18
Gastrointestinal symptoms
Time Frame: day 0, day 18
Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.
day 0, day 18

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AB Biotics, SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Maria Aldea Perona, PhD, Instituto Hospital del Mar de Investigaciones Médicas

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OLIVIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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