Probiotic Research On Safety, Palatability, Efficacy and Receptivity (PROSPER)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Probiotic Intervention
• Intervention / Treatment: Dietary supplement: Probiotic Capsule

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Connor, PhD; Phone Number: 613-520-2600; Email: kristin.connor@carleton.ca
• Study Contact Backup: Name: Tim Van Mieghem, MD, PhD; Phone Number: 416-586-4800; Email: tim.vanmieghem@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1S 5B6
      • Recruiting
      • Carleton University
      • Principal Investigator: Kristin Connor, PhD
      • Contact: Kristin Connor, PhD; Phone Number: 613-520-2600; Email: kristin.connor@carleton.ca
      • Contact: Tim Van Mieghem, MD, PhD; Phone Number: 416-586-4800; Email: tim.vanmieghem@sinaihealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic product (high dose); Probiotic product in capsule form to be consumed once per day over the course of the study.	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).
Experimental: Probiotic product (low dose); Probiotic product in capsule form to be consumed once per day over the course of the study.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline	Folate, vitamin B12 and B6 concentrations will be measured using standard clinical lab assay.	Baseline, 4 weeks
Receptivity Outcome	Participant receptivity captured using the receptivity questionnaire at baseline.	Baseline
Acceptability Outcome	Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment).	4 weeks
Safety Outcome - Reported adverse events at midline (2-week assessment) and endline (4-week assessment)	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.	2 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment)	Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).	Baseline, 4 weeks
Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment)	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.	Baseline, 4 weeks
Dietary intake - exploratory analyses at baseline and endline (4-week assessment)	The investigators will perform exploratory dietary intake analyses, including proportion of participants meeting dietary reference intakes, and dietary patterns of foods.	Baseline, 4 weeks
Dietary intake - HEI and DRI at baseline and endline (4-week assessment)	The investigators will perform exploratory dietary intake analyses, including the proportion of participants meeting the Healthy Eating Index (HEI), and Dietary Inflammatory Index (DRI).	Baseline, 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Gut microbial metagenome at baseline and endline (4-week assessment)	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).	Baseline, 4 weeks
Exploratory: Gut microbial metabolome at baseline and endline (4-week assessment)	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).	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Carleton University
• Investigators: Principal Investigator: Kristin Connor, PhD, Carleton University; Principal Investigator: Tim Van Mieghem, MD, PhD, Mount Sinai Hospital

Publications and helpful links

General Publications

• Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.
• Gloor GB, Hummelen R, Macklaim JM, Dickson RJ, Fernandes AD, MacPhee R, Reid G. Microbiome profiling by illumina sequencing of combinatorial sequence-tagged PCR products. PLoS One. 2010 Oct 26;5(10):e15406. doi: 10.1371/journal.pone.0015406.
• Gloor GB, Wu JR, Pawlowsky-Glahn V, Egozcue JJ. It's all relative: analyzing microbiome data as compositions. Ann Epidemiol. 2016 May;26(5):322-9. doi: 10.1016/j.annepidem.2016.03.003. Epub 2016 Apr 2.
• Fernandes AD, Reid JN, Macklaim JM, McMurrough TA, Edgell DR, Gloor GB. Unifying the analysis of high-throughput sequencing datasets: characterizing RNA-seq, 16S rRNA gene sequencing and selective growth experiments by compositional data analysis. Microbiome. 2014 May 5;2:15. doi: 10.1186/2049-2618-2-15. eCollection 2014.
• Abdel Rahman AM, Pawling J, Ryczko M, Caudy AA, Dennis JW. Targeted metabolomics in cultured cells and tissues by mass spectrometry: method development and validation. Anal Chim Acta. 2014 Oct 3;845:53-61. doi: 10.1016/j.aca.2014.06.012. Epub 2014 Jun 12.
• Pang Z, Lu Y, Zhou G, Hui F, Xu L, Viau C, Spigelman AF, MacDonald PE, Wishart DS, Li S, Xia J. MetaboAnalyst 6.0: towards a unified platform for metabolomics data processing, analysis and interpretation. Nucleic Acids Res. 2024 Jul 5;52(W1):W398-W406. doi: 10.1093/nar/gkae253.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; B vitamins; Reproductive-aged women
• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: 123214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No