Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women (VSS)

February 1, 2023 updated by: Lallemand Health Solutions

Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)

The aim of this trial is to detect the presence of various probiotic strains in vaginal swabs of healthy women orally consuming a probiotic supplement for 4 weeks.

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

Participants recruited from the university community in the Southeast U.S. will participate in a pilot, open-label interventional study for approximately 6 weeks following obtainment of informed consent. Participants will be asked to maintain their usual diets with the exception of probiotic supplements, probiotic fortified products or foods with added fiber supplements.

On the first day of the study, participants will take part in a 1-week pre-baseline period where they will begin daily questionnaires inquiring about gastrointestinal symptoms, stool form and number, stress, and medications taken.

On the first day of the intervention period (Day 1), participants will self collect a baseline vaginal swab sample, a skin swab, a vaginal pH swab, and a stool sample. Participants will consume 2 capsules every morning and 2 capsules every evening for four weeks (from D1 to D28).

Participants will self collect a vaginal swab sample, a skin swab, a vaginal pH swab, and a stool sample at Day 14 and at Day 28. An additional vaginal swab sample will be collected at Day 35 to assess for probiotic strains persistence.

At the conclusion of the study, participants will be instructed to return any unused supplements to the study site.

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.
8

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 Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611-0370
        • Food Science and Human Nutrition Department and the Center for Nutritional Sciences

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  1. Be a healthy female between the ages of 18 and 40 years,
  2. Have a regular and predictable menstrual cycle,
  3. Be on an oral contraceptive,
  4. Willing and able to consume a probiotic supplement for 4 weeks,
  5. Willing and able to complete daily questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits,
  6. Willing to discontinue consumption of probiotics supplements and probiotic fortified products two weeks prior the beginning of the study and throughout the study,
  7. Willing to discontinue consumption of fiber supplements,
  8. Willing to provide a stool sample two times during the study,
  9. Willing to provide one vaginal swab sample four times during the study,
  10. Willing to provide one skin swab sample (skin between the vagina and the anus), three times during the study,
  11. Typically have one stool per day,
  12. Willing to complete a pregnancy test before consuming the study supplement.

Exclusion criteria:

  1. Women who will be menstruating during the sample collection times,
  2. Women who only use condoms, barrier, spermicide, or natural methods as their sole contraceptive method,
  3. Women using any intrauterine device (IUD), birth control shot or implant,
  4. Women who are lactating, know that they are pregnant, are attempting to get pregnant or test positive on a pregnancy test,
  5. Pre-menopausal or menopausal women,
  6. Women who have used any vaginal probiotics in the previous three months,
  7. Use of oral or local antibiotics or antifungal within the past month,
  8. Currently being treated for a severe chronic disease (cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
  9. Women who have been diagnosed with any gynecological diseases or conditions (fibroma, endometriosis, etc.),
  10. Women who have been diagnosed with secondary dysmenorrhea,
  11. Women with intolerance, allergy or hypersensitivity to milk, soy or yeast,
  12. With ongoing symptoms of vaginal and/or urinary tract infection,
  13. Women using a treatment for vaginal sepsis or urosepsis.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Healthy Women
Healthy women between the ages of 18-40 years will be given a probiotic supplement to evaluate the detection and persistence of the strains in biological samples.
Dietary supplement: Probiotic
Healthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.

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
Strains detection
Time Frame: Baseline, Day 14, Day 28, Day 35
Change in presence or absence of the probiotic bacterial strains in the vaginal swab samples after 4 weeks of orally consuming the probiotic supplement.
Baseline, Day 14, Day 28, Day 35

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
Strains viability
Time Frame: Baseline, Day 14, Day 28, Day 35
Viability of the probiotic bacterial strains in the vaginal and skin swab samples.
Baseline, Day 14, Day 28, Day 35
Stool frequency
Time Frame: weekly, up to 6 weeks
Average number of stools per week.
weekly, up to 6 weeks
Stool consistency
Time Frame: weekly, up to 6 weeks
Intestinal transit time as measured by the Bristol Stool Form Scale (BSFS). The BSFS is scored between 1 (hard stool) - 7 (liquid stool).
weekly, up to 6 weeks
Stress
Time Frame: weekly, up to 6 weeks
Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).
weekly, up to 6 weeks
Vaginal pH
Time Frame: Baseline, Day 14, Day 28
Evolution of vaginal pH throughout intervention.
Baseline, Day 14, Day 28
Strains detection in skin swabs
Time Frame: Baseline, Day 14, Day 28
Presence or absence of the probiotic strains in the skin swab samples.
Baseline, Day 14, Day 28
Strains persistence
Time Frame: Baseline, Day 35
Presence or absence of the probiotic strains in the vaginal swab sample 1 week after the intervention has been completed.
Baseline, Day 35
Strains recovery in stool samples
Time Frame: Baseline, Day 28
Change from baseline in the concentration of the probiotic strains in stool samples.
Baseline, Day 28

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.
Lallemand Health Solutions

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Florida

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: Bobbi Langkamp-Henken, Ph.D., University of Florida

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.
March 8, 2021

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.
December 14, 2021

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.
December 14, 2021

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 15, 2021

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 19, 2021

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 22, 2021

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.
February 2, 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.
February 1, 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.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • L-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).

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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