Probiotic InterventionPROSPERNCT07512557
Probiotic Research On Safety, Palatability, Efficacy and Receptivity
A study testing Probiotic Capsule in people with Probiotic Intervention, run by Carleton University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Probiotic Intervention
- What is being tested?
- Probiotic Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Carleton University
Ottawa, Ontario, K1S 5B6
Kristin Connor, PhD, 613-520-2600, kristin.connor@carleton.ca
Tim Van Mieghem, MD, PhD, 416-586-4800, tim.vanmieghem@sinaihealth.ca
About this study
Official title: 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?
Read more
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
- Being tested
- Probiotic Capsule
- Keywords
- B vitamins, Reproductive-aged women, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic CapsuleDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic product (high dose) | Experimental | Probiotic product in capsule form to be consumed once per day over the course of the study. Receives: Dietary Supplement: Probiotic Capsule |
| Probiotic product (low dose) | Experimental | Probiotic product in capsule form to be consumed once per day over the course of the study. Receives: Dietary Supplement: Probiotic Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
Receptivity Outcome
Participant receptivity captured using the receptivity questionnaire at baseline.
Measured: Baseline
Acceptability Outcome
Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment).
Measured: 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.
Measured: 2 weeks, 4 weeks
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start28 Nov 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Probiotic InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, dose-masked, randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carleton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Connor, PhD, Principal investigator, Carleton UniversityTim Van Mieghem, MD, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512557
- Sponsor's protocol ID
- 123214
- Acronym
- PROSPER
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38587201Abdel 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.
PubMed 25201272Fernandes 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.
PubMed 24910773Gloor 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.
PubMed 27143475Gloor 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.
PubMed 21048977Subar 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.
PubMed 22704899
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT07512557
- Acronym / sponsor ID
- PROSPER / 123214
- Conditions
- Probiotic Intervention
- Keywords
- B vitamins, Reproductive-aged women, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Carleton UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, dose-masked, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic product (high dose) | Experimental | Dietary Supplement: Probiotic CapsuleProbiotic product in capsule form to be consumed once per day over the course of the study. |
| Probiotic product (low dose) | Experimental | Dietary Supplement: Probiotic CapsuleProbiotic product in capsule form to be consumed once per day over the course of the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic CapsuleJamieson 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). | Dietary supplement | Probiotic product (high dose), Probiotic product (low dose) |
Primary outcome
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.
Receptivity Outcome
Time frame: Baseline
Participant receptivity captured using the receptivity questionnaire at baseline.
Acceptability Outcome
Time frame: 4 weeks
Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment).
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.
4 secondary outcomes
Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment)
Time frame: Baseline, 4 weeks
Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment)
Time frame: Baseline, 4 weeks
Dietary intake - exploratory analyses at baseline and endline (4-week assessment)
Time frame: Baseline, 4 weeks
Dietary intake - HEI and DRI at baseline and endline (4-week assessment)
Time frame: Baseline, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 38587201Pang 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.
- Background: PubMed 25201272Abdel 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.
- Background: PubMed 24910773Fernandes 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.
- Background: PubMed 27143475Gloor 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.
- Background: PubMed 21048977Gloor 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.
- Background: PubMed 22704899Subar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Connor, PhD principal investigator
Carleton University
Tim Van Mieghem, MD, PhD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Capsule in people with Probiotic Intervention, run by Carleton University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Connor, PhD (613-520-2600, kristin.connor@carleton.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline (time frame: Baseline, 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512557, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.