NCT07512557 Probiotic Research On Safety, Palatability, Efficacy and Receptivity
| NCT ID | NCT07512557 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carleton University |
| Condition | Probiotic Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2025-11-28 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
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
Contact & Investigator
Kristin Connor, PhD
PRINCIPAL INVESTIGATOR
Carleton University
Frequently Asked Questions
Who can join the NCT07512557 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Probiotic Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07512557 currently recruiting?
Yes, NCT07512557 is actively recruiting participants. Contact the research team at kristin.connor@carleton.ca for enrollment information.
Where is the NCT07512557 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT07512557 clinical trial?
NCT07512557 is sponsored by Carleton University. The principal investigator is Kristin Connor, PhD at Carleton University. The trial plans to enroll 82 participants.