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

Primary Purpose

Healthy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Probiotic

About this trial

This is an interventional basic science trial for Healthy focused on measuring Probiotics, Strain recovery, Vaginal swab, Persistence

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

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

Exclusion criteria:

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

Sites / Locations

Food Science and Human Nutrition Department and the Center for Nutritional Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Women

Arm Description

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.

Outcomes

Primary Outcome Measures

Strains detection

Change in presence or absence of the probiotic bacterial strains in the vaginal swab samples after 4 weeks of orally consuming the probiotic supplement.

Secondary Outcome Measures

Strains viability

Viability of the probiotic bacterial strains in the vaginal and skin swab samples.

Stool frequency

Average number of stools per week.

Stool consistency

Intestinal transit time as measured by the Bristol Stool Form Scale (BSFS). The BSFS is scored between 1 (hard stool) - 7 (liquid stool).

Stress

Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).

Vaginal pH

Evolution of vaginal pH throughout intervention.

Strains detection in skin swabs

Presence or absence of the probiotic strains in the skin swab samples.

Strains persistence

Presence or absence of the probiotic strains in the vaginal swab sample 1 week after the intervention has been completed.

Strains recovery in stool samples

Change from baseline in the concentration of the probiotic strains in stool samples.

Full Information

NCT ID

NCT04719611

First Posted

January 15, 2021

Last Updated

February 1, 2023

Sponsor

Lallemand Health Solutions

Collaborators

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT04719611

Brief Title

Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women

Acronym

VSS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

December 14, 2021 (Actual)

Study Completion Date

December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lallemand Health Solutions

Collaborators

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Probiotics, Strain recovery, Vaginal swab, Persistence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

interventional, single-arm, open-label, pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Women

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Intervention Description

Healthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.

Primary Outcome Measure Information:

Title

Strains detection

Description

Change in presence or absence of the probiotic bacterial strains in the vaginal swab samples after 4 weeks of orally consuming the probiotic supplement.

Time Frame

Baseline, Day 14, Day 28, Day 35

Secondary Outcome Measure Information:

Title

Strains viability

Description

Viability of the probiotic bacterial strains in the vaginal and skin swab samples.

Time Frame

Baseline, Day 14, Day 28, Day 35

Title

Stool frequency

Description

Average number of stools per week.

Time Frame

weekly, up to 6 weeks

Title

Stool consistency

Description

Intestinal transit time as measured by the Bristol Stool Form Scale (BSFS). The BSFS is scored between 1 (hard stool) - 7 (liquid stool).

Time Frame

weekly, up to 6 weeks

Title

Stress

Description

Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).

Time Frame

weekly, up to 6 weeks

Title

Vaginal pH

Description

Evolution of vaginal pH throughout intervention.

Time Frame

Baseline, Day 14, Day 28

Title

Strains detection in skin swabs

Description

Presence or absence of the probiotic strains in the skin swab samples.

Time Frame

Baseline, Day 14, Day 28

Title

Strains persistence

Description

Presence or absence of the probiotic strains in the vaginal swab sample 1 week after the intervention has been completed.

Time Frame

Baseline, Day 35

Title

Strains recovery in stool samples

Description

Change from baseline in the concentration of the probiotic strains in stool samples.

Time Frame

Baseline, Day 28

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Participant must menstruate regularly and consume an oral contraceptive.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Be a healthy female between the ages of 18 and 40 years, Have a regular and predictable menstrual cycle, Be on an oral contraceptive, Willing and able to consume a probiotic supplement for 4 weeks, Willing and able to complete daily questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits, Willing to discontinue consumption of probiotics supplements and probiotic fortified products two weeks prior the beginning of the study and throughout the study, Willing to discontinue consumption of fiber supplements, Willing to provide a stool sample two times during the study, Willing to provide one vaginal swab sample four times during the study, Willing to provide one skin swab sample (skin between the vagina and the anus), three times during the study, Typically have one stool per day, Willing to complete a pregnancy test before consuming the study supplement. Exclusion criteria: Women who will be menstruating during the sample collection times, Women who only use condoms, barrier, spermicide, or natural methods as their sole contraceptive method, Women using any intrauterine device (IUD), birth control shot or implant, Women who are lactating, know that they are pregnant, are attempting to get pregnant or test positive on a pregnancy test, Pre-menopausal or menopausal women, Women who have used any vaginal probiotics in the previous three months, Use of oral or local antibiotics or antifungal within the past month, Currently being treated for a severe chronic disease (cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.), Women who have been diagnosed with any gynecological diseases or conditions (fibroma, endometriosis, etc.), Women who have been diagnosed with secondary dysmenorrhea, Women with intolerance, allergy or hypersensitivity to milk, soy or yeast, With ongoing symptoms of vaginal and/or urinary tract infection, Women using a treatment for vaginal sepsis or urosepsis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bobbi Langkamp-Henken, Ph.D.

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Food Science and Human Nutrition Department and the Center for Nutritional Sciences

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611-0370

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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).

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Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women

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