Probiotic effects on safety, palatability, and B vitamin levels in reproductive-aged women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot enrolls non-pregnant, non-lactating biologically female participants aged 18–40 who live in the greater Ottawa area and do not have micronutrient deficiencies. Participants are assigned to take either one capsule or two capsules daily of a commercially available multi-strain probiotic for 28 days. Blood samples for folate, vitamin B12, and B6 and stool samples are collected at baseline and at day 28, and participants complete online questionnaires and attend two in-person visits. Researchers will compare vitamin levels and other safety and palatability measures between the two dosing groups to see if regular probiotic intake changes B vitamin status.

Why it matters

Who can join: the full rules

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

Where it's running

• Carleton University
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Kristin Connor, PhD — Carleton University
• Study coordinator: Kristin Connor, PhD
• Email: kristin.connor@carleton.ca
• Phone: 613-520-2600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sertraline with multi-strain probiotics for adolescents with depression

  This study tests whether adding multi-strain probiotics to sertraline helps teens (ages 12–18) with major depressive disorder feel better than sertraline with a placebo.

  Recruiting Phase 2 First Affiliated Hospital of Chongqing Medical University · Chongqing, Yuzhong · NCT07645157

• Sertraline plus a probiotic (Lactobacillus crispatus) for teens with depression

  This study tests whether adding Lactobacillus crispatus to sertraline helps reduce depressive symptoms in adolescents with major depressive disorder.

  Recruiting Phase 2 First Affiliated Hospital of Chongqing Medical University · Longgang, Chongqing Municipality and 1 other locations · NCT07539805

• Probiotic 6600 as an add-on treatment for ulcerative colitis, Crohn's disease, and colitis

  This trial will test whether adding Probiotic 6600 to usual care helps adults with ulcerative colitis, Crohn's disease, or nonspecific colitis reach clinical remission over 24 weeks.

  Recruiting Phase 2/3 Changhai Hospital · Shanghai · NCT07047339

• Probiotic or semaglutide plus diet to reduce body weight

  This project will test whether adding a probiotic (Lactobacillus paracasei LC-19) or semaglutide to a calorie-restricted diet helps overweight adults lose weight and improve blood sugar and lipid levels.

  Recruiting Chinese Academy of Sciences · Hangzhou, Zhejiang · NCT06989177

• Probiotics for improving pulmonary rehabilitation in COPD patients

  This study is testing if taking probiotics can help people with COPD feel better and improve their results during pulmonary rehabilitation.

  Recruiting Fu Jen Catholic University · New Taipei City · NCT06717659

• Barley and kefir to support gut health in active adults

  This study tests whether a daily barley and kefir meal for four weeks can change gut microbiota in physically active adults and whether those changes relate to certain metabolites in blood and urine.

  Recruiting Western Norway University of Applied Sciences · Bergen · NCT07864779

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.