Probiotic Research On Safety, Palatability, Efficacy and Receptivity

Official title

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

Overview

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)

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), Lactobac

Primary outcome measures

• 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]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

Canada · 1 center

• Carleton University — Ottawa

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. PMID 38587201
• 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. PMID 25201272
• 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. PMID 24910773
• 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. PMID 27143475
• 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. PMID 21048977
• 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. PMID 22704899

Identifiers

NCT: NCT07512557 · 123214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗