Comparing 3 approaches for focus is on healthy subjects
Official title: Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults
- Phase 2
- 3 groups
- One site, in Montreal
- Recruiting
Interventions
- Other intervention
Probiotic Formula 1
Probiotic Formula 1
- Other intervention
Probiotic Formula 2
Probiotic Formula 2
- Other intervention
Probiotic Formula 3
Probiotic Formula 3
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Evalulab
Montreal
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Clinically healthy female between the ages of 18 and 50 years, inclusive,
- +have a regular or predictable menstrual cycle
- +Typically have regular bowel movements,
- +Willing and able to consume a probiotic supplement for 4 weeks,
- +Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,
- +Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,
- +Willing to provide 1 stool sample 4 times throughout the study,
- +Willing to provide 2 vaginal swabs 4 times throughout the study,
- +Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,
- +Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,
- +Willing to complete a pregnancy test at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →.
Exclusion
- −Intolerance, allergy or sensitivity to milk, soy, or yeast.
- −Menopausal women,
- −Vaginal pH \< 2 or \> 5 measured at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →,
- −Menstruation during the sample collection times,
- −Use of vaginal probiotics in the last 3 months,
- −Use of local vaginal antibiotics or antifungals in the last 3 months.
- −Use of oral antibiotics or antifungals in the last month,
- −Ongoing symptoms of vaginal and/or urinary tract infections,
- −Current treatment for vaginal sepsis or urosepsis,
- −Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
- −Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),
- −Clinical diagnosis of secondary dysmenorrhea,
- −Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Probiotic Formula 1.
Registry label: A: Group 1
Group B receives Probiotic Formula 2.
Registry label: B: Group 2
Group C receives Probiotic Formula 3.
Registry label: C: Group 3
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 50 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 72 people.
The study is currently expected to finish around October 2026.
The main measurement is taken over: 28 days of oral intake.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake — measured over 28 days of oral intake.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07246161 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Probiotic Formula 1Other
Probiotic Formula 1
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Probiotic Formula 2Other
Probiotic Formula 2
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Probiotic Formula 3Other
Probiotic Formula 3
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 50 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 28 days of oral intake.
The study as a whole is currently expected to finish around 2026-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 72 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.