Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single-blind, dose-masked trial with blinded investigator allocation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Probiotic product (low dose)
Probiotic product in capsule form to be consumed once per day over the course of the study.
干预措施: Probiotic Capsule (Dietary Supplement)
Probiotic product (high dose)
Probiotic product in capsule form to be consumed once per day over the course of the study.
干预措施: Probiotic Capsule (Dietary Supplement)
结局指标
主要结局
Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline
时间窗: Baseline, 4 weeks
Folate, vitamin B12 and B6 concentrations will be measured using standard clinical lab assay.
Receptivity Outcome
时间窗: Baseline
Participant receptivity captured using the receptivity questionnaire at baseline.
Acceptability Outcome
时间窗: 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)
时间窗: 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.
次要结局
- Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment)(Baseline, 4 weeks)
- Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment)(Baseline, 4 weeks)
- Dietary intake - exploratory analyses at baseline and endline (4-week assessment)(Baseline, 4 weeks)
- Dietary intake - HEI and DRI at baseline and endline (4-week assessment)(Baseline, 4 weeks)