Healthy
Conditions
Keywords
Probiotics, Strain recovery, Vaginal swab, Persistence
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Healthy women receive a probiotic supplement containing 6 x 10\^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.
Sponsors
University of Florida
Lallemand Health Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
interventional, single-arm, open-label, pilot study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strains detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency | weekly, up to 6 weeks | Average number of stools per week. |
| Stool consistency | 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). |
| Stress | weekly, up to 6 weeks | Measured daily on a scale between 1 (no stress) to 10 (extremely stressed). |
| Strains viability | Baseline, Day 14, Day 28, Day 35 | Viability of the probiotic bacterial strains in the vaginal and skin swab samples. |
| Strains detection in skin swabs | Baseline, Day 14, Day 28 | Presence or absence of the probiotic strains in the skin swab samples. |
| Strains persistence | Baseline, Day 35 | 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 | Baseline, Day 28 | Change from baseline in the concentration of the probiotic strains in stool samples. |
| Vaginal pH | Baseline, Day 14, Day 28 | Evolution of vaginal pH throughout intervention. |
Countries
United States
Outcome results
None listed