HealthyVSSNCT04719611
Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women
A study testing Probiotic in people with Healthy, run by Lallemand Health Solutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 14 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Human Nutrition Department and the Center for Nutritional Sciences
Gainesville, Florida, 32611-0370
About this study
Official title: Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Healthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14, Day 28, Day 35
Secondary outcomes (8)
Strains viability
Viability of the probiotic bacterial strains in the vaginal and skin swab samples.
Measured: Baseline, Day 14, Day 28, Day 35
Stool frequency
Average number of stools per week.
Measured: weekly, up to 6 weeks
Stool consistency
Intestinal transit time as measured by the Bristol Stool Form Scale (BSFS). The BSFS is scored between 1 (hard stool) - 7 (liquid stool).
Measured: weekly, up to 6 weeks
Stress
Measured daily on a scale between 1 (no stress) to 10 (extremely stressed).
Measured: weekly, up to 6 weeks
Vaginal pH
Evolution of vaginal pH throughout intervention.
Measured: Baseline, Day 14, Day 28
Strains detection in skin swabs
Presence or absence of the probiotic strains in the skin swab samples.
Measured: Baseline, Day 14, Day 28
Strains persistence
Presence or absence of the probiotic strains in the vaginal swab sample 1 week after the intervention has been completed.
Measured: Baseline, Day 35
Strains recovery in stool samples
Change from baseline in the concentration of the probiotic strains in stool samples.
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start8 Mar 2021
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional, single-arm, open-label, pilot study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719611
- Sponsor's protocol ID
- L-021
- Acronym
- VSS
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Adults Consuming a Probiotic Supplement: a Pilot Study (VSS)
- ClinicalTrials.gov ID
- NCT04719611
- Acronym / sponsor ID
- VSS / L-021
- Conditions
- Healthy
- Keywords
- Probiotics, Strain recovery, Vaginal swab, Persistence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional, single-arm, open-label, pilot study
| Arm | Type | Receives |
|---|---|---|
| Healthy Women | Experimental | Dietary Supplement: ProbioticHealthy 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticHealthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains. | Dietary supplement | Healthy Women |
Primary outcome
Strains detection
Time frame: 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.
8 secondary outcomes
Strains viability
Time frame: Baseline, Day 14, Day 28, Day 35
Stool frequency
Time frame: weekly, up to 6 weeks
Stool consistency
Time frame: weekly, up to 6 weeks
Stress
Time frame: weekly, up to 6 weeks
Vaginal pH
Time frame: Baseline, Day 14, Day 28
Strains detection in skin swabs
Time frame: Baseline, Day 14, Day 28
Strains persistence
Time frame: Baseline, Day 35
Strains recovery in stool samples
Time frame: Baseline, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No. After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbi Langkamp-Henken, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy, run by Lallemand Health Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strains detection (time frame: Baseline, Day 14, Day 28, Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.