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Probiotic Research On Safety, Palatability, Efficacy and Receptivity

NCT07512557 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-04-06

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Carleton University

    lead OTHER

Principal Investigators

  • Kristin Connor, PhD · Carleton University

  • Tim Van Mieghem, MD, PhD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2026-05-30
Completion
2026-07-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512557 on ClinicalTrials.gov