NCT04719611

Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women

Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Healthy women receive a probiotic supplement containing 6 x 10\^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2021-01-22
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States