NCT07512557

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Carleton University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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)

Conditions

• Probiotic Intervention

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Capsule	Jamieson 10 Billion Daily Maintenance Probiotic. The probiotic formulation contains Bifidobacterium animalis subsp. lactis (UABla-12), Lactobacillus paracasei (UALpc-04), Bifidobacterium breve (UABbr-11), Lactobacillus gasseri (UALg-05), Lactobacillus rhamnosus (UALr-06), Lactobacillus rhamnosus (UALr-18), Lactobacillus acidophilus (DDS-1), Lactobacillus plantarum (UALp-05), Bifidobacterium longum subsp. longum (UABl-14), Bifidobacterium bifidum (UABb-10), Lactobacillus casei (UALc-03), Lactobacillus reuteri (UALre-16), Lactococcus lactis (UALl-08), and Bifidobacterium longum subsp. infantis (UABi-13).

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-05-30
• Completion: 2026-07-30
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Canada