💬In plain words
What the trial is, and whether it could suit you
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 endli
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Non-pregnant and non-lactating
* English speaking with the ability to give informed consent
* 18-40 years of age (inclusive)
* 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
Exclusion Criteria:
* Individuals who are lactating, pregnant, or planning to become pregnant during the study
* Individuals who are not maintaining adequate birth control measures
* 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 a known sensitivity, intolerability, or allergy to any of the study products or their excipients
* 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
* Have planned surgery during the course of the study
* Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration
* Taking probiotics during the study period
* More than 2 alcoholic beverages per day throughout the duration 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
Carleton University
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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