Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women

NCT04719611 | Completed

• 1 other identifier: L-021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Probiotics; Strain recovery; Vaginal swab; Persistence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 14, Day 28, Day 35

Secondary Outcomes (8)

• Strains viability

  Baseline, Day 14, Day 28, Day 35

• Stool frequency

  weekly, up to 6 weeks

• Stool consistency

  weekly, up to 6 weeks

• Stress

  weekly, up to 6 weeks

• Vaginal pH

  Baseline, Day 14, Day 28

Study Arms (1)

Healthy Women

EXPERIMENTAL

Healthy women between the ages of 18-40 years will be given a probiotic supplement to evaluate the detection and persistence of the strains in biological samples.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Healthy Women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Participant must menstruate regularly and consume an oral contraceptive.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• University of Florida: collaborator

Study Sites (1)

Food Science and Human Nutrition Department and the Center for Nutritional Sciences

Gainesville, Florida, 32611-0370, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bobbi Langkamp-Henken, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: interventional, single-arm, open-label, pilot study

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: March 8, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)