Status:
COMPLETED
Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women
Lead Sponsor:
Lallemand Health Solutions
Collaborating Sponsors:
University of Florida
Conditions:
Healthy
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 conse...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Be a healthy female between the ages of 18 and 40 years,
- Have a regular and predictable menstrual cycle,
- Be on an oral contraceptive,
- Willing and able to consume a probiotic supplement for 4 weeks,
- Willing and able to complete daily questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits,
- Willing to discontinue consumption of probiotics supplements and probiotic fortified products two weeks prior the beginning of the study and throughout the study,
- Willing to discontinue consumption of fiber supplements,
- Willing to provide a stool sample two times during the study,
- Willing to provide one vaginal swab sample four times during the study,
- Willing to provide one skin swab sample (skin between the vagina and the anus), three times during the study,
- Typically have one stool per day,
- Willing to complete a pregnancy test before consuming the study supplement.
- Exclusion criteria:
- Women who will be menstruating during the sample collection times,
- Women who only use condoms, barrier, spermicide, or natural methods as their sole contraceptive method,
- Women using any intrauterine device (IUD), birth control shot or implant,
- Women who are lactating, know that they are pregnant, are attempting to get pregnant or test positive on a pregnancy test,
- Pre-menopausal or menopausal women,
- Women who have used any vaginal probiotics in the previous three months,
- Use of oral or local antibiotics or antifungal within the past month,
- Currently being treated for a severe chronic disease (cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
- Women who have been diagnosed with any gynecological diseases or conditions (fibroma, endometriosis, etc.),
- Women who have been diagnosed with secondary dysmenorrhea,
- Women with intolerance, allergy or hypersensitivity to milk, soy or yeast,
- With ongoing symptoms of vaginal and/or urinary tract infection,
- Women using a treatment for vaginal sepsis or urosepsis.
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04719611
Start Date
March 8 2021
End Date
December 14 2021
Last Update
February 2 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Food Science and Human Nutrition Department and the Center for Nutritional Sciences
Gainesville, Florida, United States, 32611-0370