Recruiting

Probiotic Product

Sponsor:

Carleton University

Code:

NCT07512557

Conditions

Probiotic Intervention

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Probiotic Capsule

Study Details

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)

Conditions

Probiotic Intervention

Study ID

NCT07512557

Start date

Nov 28, 2025

Status verified date

Apr, 2026

Completion date

Jul 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Probiotic product (high dose)

Probiotic product in capsule form to be consumed once per day over the course of the study.

experimental: Probiotic product (low dose)

Probiotic product in capsule form to be consumed once per day over the course of the study.

Interventions

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).

Primary outcome measure

  • Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline [ Time Frame: Baseline, 4 weeks ]
  • Receptivity Outcome [ Time Frame: Baseline ]
  • Acceptability Outcome [ Time Frame: 4 weeks ]
  • Safety Outcome - Reported adverse events at midline (2-week assessment) and endline (4-week assessment) [ Time Frame: 2 weeks, 4 weeks ]

Central Contacts and Locations

Central contacts

Kristin Connor, PhD

613-520-2600kristin.connor@carleton.ca

Tim Van Mieghem, MD, PhD

416-586-4800tim.vanmieghem@sinaihealth.ca

Locations

Carleton University

Recruiting

Ottawa, Ontario, Canada, K1S 5B6

Contacts

Kristin Connor, PhD

613-520-2600kristin.connor@carleton.ca

Tim Van Mieghem, MD, PhD

416-586-4800tim.vanmieghem@sinaihealth.ca

Principal Investigator:

Kristin Connor, PhD

More Information

Sponsor

Carleton University

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • B vitamins
  • Reproductive-aged women
  • Probiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carleton University on 2026-04-06.