Actively Recruiting
Probiotic Research On Safety, Palatability, Efficacy and Receptivity
Led by Carleton University · Updated on 2026-04-06
82
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Probiotic Research On Safety, Palatability, Efficacy and Receptivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-pregnant and non-lactating
- English speaking with the ability to give informed consent
- Age between 18 and 40 years (inclusive)
- Women who are biologically female
- Willing and able to agree to the study requirements and lifestyle restrictions
- Able to understand and complete questionnaires in English and carry out study procedures
- Located in the greater Ottawa area and a resident of Ontario
You will not qualify if you...
- Currently pregnant, lactating, or planning to become pregnant during the study
- Not using adequate birth control measures during the study
- Known allergy or intolerance to any study products or their components
- Using vitamin or mineral supplements containing B vitamins
- Taken B-vitamin supplements or probiotics in the past 4 weeks
- Planning to change diet or exercise routines during the study
- Scheduled for surgery during the study period
- Participation in another research study involving investigational products within 30 days before baseline or during the study
- Taking probiotics during the study
- Consuming more than 2 alcoholic drinks per day during the study
- History of gastrointestinal disorders such as celiac disease, ulcerative colitis, Crohn's disease, gastric cancer, gastric polyps, inflammatory bowel disease, Helicobacter pylori infection, gastrectomy, duodenal bypass, or bariatric surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Carleton University
Ottawa, Ontario, Canada, K1S 5B6
Actively Recruiting
Research Team
K
Kristin Connor, PhD
CONTACT
T
Tim Van Mieghem, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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