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

• ClinicalTrials.gov Identifier: NCT04719611
• Recruitment Status: Active, not recruiting
• First Posted: January 22, 2021
• Last Update Posted: February 8, 2022
• Sponsor: Lallemand Health Solutions
• Collaborator: University of Florida
• Information provided by (Responsible Party): Lallemand Health Solutions

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Probiotic	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: interventional, single-arm, open-label, pilot study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)
• Actual Study Start Date: March 8, 2021
• Actual Primary Completion Date: December 6, 2021
• Estimated Study Completion Date: February 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Strains viability [ Time Frame: Baseline, Day 14, Day 28, Day 35 ]
   Viability of the probiotic bacterial strains in the vaginal and skin swab samples.
2. Stool frequency [ Time Frame: weekly, up to 6 weeks ]
   Average number of stools per week.
3. 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).
4. Stress [ Time Frame: weekly, up to 6 weeks ]
   Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).
5. Vaginal pH [ Time Frame: Baseline, Day 14, Day 28 ]
   Evolution of vaginal pH throughout intervention.
6. Strains detection in skin swabs [ Time Frame: Baseline, Day 14, Day 28 ]
   Presence or absence of the probiotic strains in the skin swab samples.
7. 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.
8. Strains recovery in stool samples [ Time Frame: Baseline, Day 28 ]
   Change from baseline in the concentration of the probiotic strains in stool samples.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Participant must menstruate regularly and consume an oral contraceptive.
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

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

Gainesville, Florida, United States, 32611-0370

Sponsors and Collaborators

Lallemand Health Solutions

University of Florida

Investigators

• Principal Investigator: Bobbi Langkamp-Henken, Ph.D.; University of Florida

More Information

• Responsible Party: Lallemand Health Solutions
• ClinicalTrials.gov Identifier: NCT04719611
• Other Study ID Numbers: L-021
• First Posted: January 22, 2021
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lallemand Health Solutions:

Probiotics; Strain recovery; Vaginal swab; Persistence

Additional relevant MeSH terms:

Sprains and Strains; Wounds and Injuries