Testing Probiotic for probiotic intervention
Official title: Probiotic Research On Safety, Palatability, Efficacy and Receptivity
Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study
- 2 groups
- One site, in Ottawa
- Recruiting
Interventions
- Other intervention
Probiotic Capsule
Jamieson 10 Billion Daily Maintenance Probiotic. The probiotic formulation contains Bifidobacterium animalis subsp. lactis (UABla-12), Lactobacillus paracasei (UALpc-04), Bifidobacterium breve (UABbr-11), Lactobacillus gasseri (UALg-05), Lactobacillus rhamnosus (UALr-06), Lactobacillus rhamnosus (UALr-18), Lactobacillus acidophilus (DDS-1), Lactobacillus plantarum (UALp-05), Bifidobacterium longum subsp. longum (UABl-14), Bifidobacterium bifidum (UABb-10), Lactobacillus casei (UALc-03), Lactobacillus reuteri (UALre-16), Lactococcus lactis (UALl-08), and Bifidobacterium longum subsp. infantis (UABi-13).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Carleton University
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18-40 years of age (inclusive)
- +English speaking with the ability to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Women who are biologically female
- +Willing and able to agree to the requirements and lifestyle restrictions of this study
- +Able to understand and read the questionnaires in English and carry out all study-related procedures
- +Located in the greater Ottawa area and a resident of Ontario
- +Non-pregnant and non-lactating
Exclusion
- −Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
- −Individuals who are not maintaining adequate birth controlControl groupThe group a new treatment is measured against.Read more → measures
- −Are using vitamin and mineral supplements containing B vitamins
- −Intake of a B-vitamin-containing micronutrient supplement or probiotic product in the previous 4 weeks
- −Expecting to change diet and exercise regimen in the next 4 weeks
- −Use of investigational product(s) in another research study within 30 days prior to the baseline visitBaselineYour starting measurements, taken before treatment begins.Read more → or during the study duration
- −Taking probiotics during the study period
- −More than 2 alcoholic beverages per day throughout the duration of the study
- −Individuals who are lactating, pregnant, or planning to become pregnant during the study
- −Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions
- −Have planned surgery during the course of the study
- −Known medical history of specific conditions including: Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease; Gastric cancer and gastric polyps; Inflammatory bowel diseases; Helicobacter pylori infection; Gastrectomy, duodenal bypass, bariatric surgery
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 is investigating how something functions in the body, rather than testing a treatment directly.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive Probiotic Capsule.
Registry label: A: Probiotic product (high dose) · B: Probiotic product (low dose)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
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 40 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 82 people.
The study is currently expected to finish around July 2026.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 4 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baselineBaselineYour starting measurements, taken before treatment begins.Read more → — measured over Baseline, 4 weeks.
Receptivity Outcome — measured over Baseline.
Acceptability Outcome — measured over 4 weeks.
Safety Outcome - Reported adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → at midline (2-week assessment) and endline (4-week assessment) — measured over 2 weeks, 4 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07512557 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 CapsuleDietary supplement
Jamieson 10 Billion Daily Maintenance Probiotic. The probiotic formulation contains Bifidobacterium animalis subsp. lactis (UABla-12), Lactobacillus paracasei (UALpc-04), Bifidobacterium breve (UABbr-11), Lactobacillus gasseri (UALg-05), Lactobacillus rhamnosus (UALr-06), Lactobacillus rhamnosus (UALr-18), Lactobacillus acidophilus (DDS-1), Lactobacillus plantarum (UALp-05), Bifidobacterium longum subsp. longum (UABl-14), Bifidobacterium bifidum (UABb-10), Lactobacillus casei (UALc-03), Lactobacillus reuteri (UALre-16), Lactococcus lactis (UALl-08), and Bifidobacterium longum subsp. infantis (UABi-13).
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
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 40 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?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 40 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: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 4 weeks.
The study as a whole is currently expected to finish around 2026-07-30.
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 82 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Ontario, 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 goal of this pilot study is to determine if taking a commercially available probiotic product can influence levels of vitamins B12, B6 and folate after a 4-week supplementation period in reproductive-aged women without any micronutrient deficiencies. The main question it aims to answer is: • Does a probiotic product influence blood folate, vitamin B12 and B6 levels in reproductive-aged women when it is taken regularly for 4 weeks? Participants in this clinical trial will consume the probiotic product containing multiple probiotic strains regularly for 4 weeks. One group will consume one capsule per day at a particular dose, and the second group will consume two capsules per day at another dose. Participants will also have to: * Attend two in-person visits with a researcher: at enrolment (baseline), and endline (day 28/4 weeks) * Provide a blood sample at baseline (day 0) and endline (day 28/4 weeks) * Provide two stool samples (following each in-person visit) * Complete an online "study diary" every two weeks for 4 weeks (2 study diaries) * Complete two sets of online questionnaires (following each in-person visit) * Complete two sets of dietary assessments (following each in-person visit)
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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.