Clinical trial NCT04719611: Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women
Official title: Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Probiotics
Strain recovery
Vaginal swab
Persistence
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: University of Florida
First posted: 2021-01-22
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional, single-arm, open-label, pilot study
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Strains detection
timeFrame: Baseline, Day 14, Day 28, Day 35
Secondary outcomes:
measure: Strains viability
timeFrame: Baseline, Day 14, Day 28, Day 35
measure: Stool frequency
timeFrame: weekly, up to 6 weeks
measure: Stool consistency
timeFrame: weekly, up to 6 weeks
measure: Stress
timeFrame: weekly, up to 6 weeks
measure: Vaginal pH
timeFrame: Baseline, Day 14, Day 28
measure: Strains detection in skin swabs
timeFrame: Baseline, Day 14, Day 28
measure: Strains persistence
timeFrame: Baseline, Day 35
measure: Strains recovery in stool samples
timeFrame: Baseline, Day 28
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition Department and the Center for Nutritional Sciences
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: