Probiotic Research On Safety, Palatability, Efficacy and Receptivity
Recruiting now · Not applicable
Conditions studied: Probiotic Intervention
In brief
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)
Key facts
- Study ID
- NCT07512557
- Run by
- Carleton University
- People needed
- 82
- Starts
- 2025-11-28
- Expected to finish
- 2026-07-30
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Carleton University — Ottawa, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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