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.
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
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Healthy women receive a probiotic supplement containing 6 x 10\^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.
Food Science and Human Nutrition Department and the Center for Nutritional Sciences
Gainesville, Florida, United States
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.
Time frame: Baseline, Day 14, Day 28, Day 35
Strains viability
Viability of the probiotic bacterial strains in the vaginal and skin swab samples.
Time frame: Baseline, Day 14, Day 28, Day 35
Stool frequency
Average number of stools per week.
Time frame: 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).
Time frame: weekly, up to 6 weeks
Stress
Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).
Time frame: weekly, up to 6 weeks
Vaginal pH
Evolution of vaginal pH throughout intervention.
Time frame: Baseline, Day 14, Day 28
Strains detection in skin swabs
Presence or absence of the probiotic strains in the skin swab samples.
Time frame: 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.
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Time frame: Baseline, Day 35
Strains recovery in stool samples
Change from baseline in the concentration of the probiotic strains in stool samples.
Time frame: Baseline, Day 28