Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT04719611
• Lead Sponsor: Lallemand Health Solutions

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.

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-03-08
• Primary Completion: 2021-12-14
• Study Completion: 2021-12-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Strains viability	Baseline, Day 14, Day 28, Day 35	Viability of the probiotic bacterial strains in the vaginal and skin swab samples.
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).
Vaginal pH	Baseline, Day 14, Day 28	Evolution of vaginal pH throughout intervention.
Stress	weekly, up to 6 weeks	Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).
Strains detection in skin swabs	Baseline, Day 14, Day 28	Presence or absence of the probiotic strains in the skin swab samples.
Stool frequency	weekly, up to 6 weeks	Average number of stools per week.

Trial Locations

Locations (1)

Food Science and Human Nutrition Department and the Center for Nutritional Sciences; 🇺🇸 Gainesville, Florida, United States