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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotic

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: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 14, Day 28, Day 35

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Collaborators: University of Florida
• Investigators: Principal Investigator: Bobbi Langkamp-Henken, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics; Persistence; Strain recovery; Vaginal swab
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID 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