Probiotic effects on safety, palatability, and B vitamin levels in reproductive-aged women
Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study
This pilot tests whether taking a daily probiotic for 4 weeks changes blood levels of folate, vitamin B12, and B6 in reproductive-aged women without vitamin deficiencies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Carleton University Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07512557 on ClinicalTrials.gov |
What this trial studies
This pilot enrolls non-pregnant, non-lactating biologically female participants aged 18–40 who live in the greater Ottawa area and do not have micronutrient deficiencies. Participants are assigned to take either one capsule or two capsules daily of a commercially available multi-strain probiotic for 28 days. Blood samples for folate, vitamin B12, and B6 and stool samples are collected at baseline and at day 28, and participants complete online questionnaires and attend two in-person visits. Researchers will compare vitamin levels and other safety and palatability measures between the two dosing groups to see if regular probiotic intake changes B vitamin status.
Who should consider this trial
Good fit: Ideal candidates are biologically female, non-pregnant and non-lactating adults aged 18–40 who live in the greater Ottawa area, have no micronutrient deficiencies, and can attend two in-person visits and provide blood and stool samples.
Not a fit: People who are pregnant, breastfeeding, planning pregnancy, not using adequate birth control, taking vitamin/mineral supplements, allergic to probiotic ingredients, or living outside the study area are unlikely to benefit from or be eligible for this study.
Why it matters
Potential benefit: If successful, this could offer a simple supplement option to help maintain or modestly increase B vitamin levels in reproductive-aged women.
How similar studies have performed: Laboratory work and small clinical studies suggest some probiotic strains can produce or influence B vitamins, but randomized data in healthy reproductive-aged women are limited and mixed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- Carleton University — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kristin Connor, PhD — Carleton University
- Study coordinator: Kristin Connor, PhD
- Email: kristin.connor@carleton.ca
- Phone: 613-520-2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.