Probiotic Research On Safety, Palatability, Efficacy and Receptivity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorCarleton University

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Probiotic Capsule

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators