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NCT Number: NCT07512557

Probiotic Research On Safety, Palatability, Efficacy and Receptivity

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)

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Key information

Conditions

Probiotic Intervention

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic capsule

Dietary Supplement

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 outcomes

  1. Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline

    Time frame: Baseline, 4 weeks

    Folate, vitamin B12 and B6 concentrations will be measured using standard clinical lab assay.

  2. Receptivity Outcome

    Time frame: Baseline

    Participant receptivity captured using the receptivity questionnaire at baseline.

  3. Acceptability Outcome

    Time frame: 4 weeks

    Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment).

  4. Safety Outcome - Reported adverse events at midline (2-week assessment) and endline (4-week assessment)

    Time frame: 2 weeks, 4 weeks

    Reported adverse events, including detailed information related to these adverse events (e.g. frequency, severity, symptoms, timing), will be measured using the bi-weekly study diaries at midline and endline. Proportion of adverse events (AEs) will be measured at midline and endline.

Secondary outcomes

  1. Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).

  2. Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    Dietary recalls will be conducted using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) for Canada 2018 (1). This tool measures all food and beverages consumed over a 24-hour period. Dietary recalls will be considered complete if participants provide a minimum of two days of 24-hour recalls.

  3. Dietary intake - exploratory analyses at baseline and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    The investigators will perform exploratory dietary intake analyses, including proportion of participants meeting dietary reference intakes, and dietary patterns of foods.

  4. Dietary intake - HEI and DRI at baseline and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    The investigators will perform exploratory dietary intake analyses, including the proportion of participants meeting the Healthy Eating Index (HEI), and Dietary Inflammatory Index (DRI).

Other outcomes

  1. Exploratory: Gut microbial metagenome at baseline and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    Bacterial genomic DNA will be isolated from stool samples and analysed by whole genome sequencing. Exploratory analyses of inferred function of the metagenome will be undertaken using compositional approaches and standardised pipelines to summarise relative taxonomic abundance, diversity and variance within and between groups (2,3). We will further assess metagenome inferred function (mapping reads to KEGG and HUMAnN3), and visualise using compositional and scale-aware approaches (4) (and relate to computationally-derived functions from metagenome data) by measuring functional metabolites (see outcome 7 for additional details).

  2. Exploratory: Gut microbial metabolome at baseline and endline (4-week assessment)

    Time frame: Baseline, 4 weeks

    Microbial metabolome (microbial products, short chain fatty acids, vitamins, metals/minerals) will be measured in both groups (5) and data related to computationally-derived functions from metagenome data) using LC-MS and ICP-MS. Data will be processed under standard pipelines with visualisation and pathway analysis by MetaboAnalyst and KEGG databases (6).

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Connor, PhD

CONTACT

[email protected]

613-520-2600

Tim Van Mieghem, MD, PhD

CONTACT

[email protected]

416-586-4800

Sponsors and collaborators

Lead sponsor

Carleton University

Other

Registry information

Official study title

Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study

Acronym: PROSPER

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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