Vaginal HealthNCT03543982
Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health
A study testing Oral probiotic product in people with Vaginal Health, run by UAS Labs LLC at 1 site in Canada.
Trial summary
The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health
- What is being tested?
- Oral probiotic product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2018to 18 Mar 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 18-50 years.
- Body mass index 18.5 - 34.9 kg/m2 (inclusive).
- Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)].
- Non-smoker, or ex-smoker ≥6 months.
- Nugent score of 4-6 or pH >4.5
- Agrees to maintain current level of physical activity and dietary habits throughout the trial period.
Show all 9Show fewer
- Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics.
- Willing and able to provide written informed consent.
- Agrees to provide fecal samples during the trial period.
Who cannot join
- Hypersensitivity to any ingredient in the study product.
- Pregnancy or planning pregnancy.
- Lactation or breast feeding.
- Irregular menstrual cycles.
- Use of contraceptives that contain spermicidal agents.
- Use of an intrauterine device (IUD).
Show all 23Show fewer
- Use of hormonal therapy through cervical cap.
- Use of douching devices.
- Any major trauma or surgical event within the 3 months prior to screening.
- Individuals undergoing therapies to prevent any recurrent infections.
- Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.
- Use of prescription drugs (other than birth control) within 1 month prior to Visit 1.
- Use of antibiotics within 2 months prior to Visit 1.
- History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- Presence of systemic diseases or immunodeficiencies
- Abdominal or gastrointestinal surgery within the previous 12 months.
- Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1)
- History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
- Abnormal laboratory test results of clinical significance
- Presence or history (past 6 months) of alcohol or drug abuse
- Subject is unwilling or unable to abide by the requirements of the protocol
- Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
- Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health
The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.
- Conditions
- Vaginal Health
- Being tested
- Oral probiotic product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral probiotic productDietary supplement
Once per day (QD), 28 days
| Study group | Role | What they receive |
|---|---|---|
| Oral probiotic product | Experimental | Not described Receives: Dietary Supplement: Oral probiotic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vaginal microbial community, via next generation sequencing.
Measured: Day 28
Secondary outcomes (6)
Changes in vaginal microbial community, via next generation sequencing.
Measured: Day 14 and 42
Changes in vaginal pH.
Measured: Day 14, 28 and 42
Changes in Nugent Score (Scale of 0 to 10).
Measured: Day 14, 28 and 42
Parameters of well-being, via Vulvovaginal Symptom Questionnaire.
Measured: Day 14, 28 and 42
Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.
Measured: Day 14, 28 and 42
Compliance as assessed by capsule counts of the returned IP.
Measured: Day 14, 28 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start23 May 2018
- Primary completion1 Oct 2020
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- UAS Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543982
- Sponsor's protocol ID
- UAS1RPD-160001-PRVH
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health
- ClinicalTrials.gov ID
- NCT03543982
- Acronym / sponsor ID
- UAS1RPD-160001-PRVH
- Conditions
- Vaginal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- UAS Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 1 Jun 2018 (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 purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral probiotic product | Experimental | Dietary Supplement: Oral probiotic product |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy women aged 18-50 years.
- Body mass index 18.5 - 34.9 kg/m2 (inclusive).
- Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)].
- Non-smoker, or ex-smoker ≥6 months.
- Nugent score of 4-6 or pH >4.5
Key exclusion criteria (23 listed)
- Hypersensitivity to any ingredient in the study product.
- Pregnancy or planning pregnancy.
- Lactation or breast feeding.
- Irregular menstrual cycles.
- Use of contraceptives that contain spermicidal agents.
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 |
|---|---|---|
| Oral probiotic productOnce per day (QD), 28 days | Dietary supplement | Oral probiotic product |
Primary outcome
Changes in vaginal microbial community, via next generation sequencing.
Time frame: Day 28
6 secondary outcomes
Changes in vaginal microbial community, via next generation sequencing.
Time frame: Day 14 and 42
Changes in vaginal pH.
Time frame: Day 14, 28 and 42
Changes in Nugent Score (Scale of 0 to 10).
Time frame: Day 14, 28 and 42
Parameters of well-being, via Vulvovaginal Symptom Questionnaire.
Time frame: Day 14, 28 and 42
Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.
Time frame: Day 14, 28 and 42
Compliance as assessed by capsule counts of the returned IP.
Time frame: Day 14, 28 and 42
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 8 Apr 2021.
Related trials for Vaginal Health
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Not yet recruiting
BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
Healthy Subjects, HPV
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
Recruiting
A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral probiotic product in people with Vaginal Health, run by UAS Labs LLC at 1 site in Canada.
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 9 inclusion and 23 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 8 Apr 2021. 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 Canada. 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?
Changes in vaginal microbial community, via next generation sequencing. (time frame: Day 28). 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 8 Apr 2021.