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

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)

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