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Tests treatment safety and results for Probiotic Intervention
Official title Probiotic Research On Safety, Palatability, Efficacy and Receptivity
ClinicalTrials.gov ID: NCT07512557
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.