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Probiotic Capsule for Vitamin Levels

(PROSPER Trial)

KC
TV
Overseen ByTim Van Mieghem, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a probiotic capsule can boost levels of vitamins B12, B6, and folate in women of childbearing age. Participants will take either a high or low dose of the probiotic daily for four weeks and provide blood and stool samples to assess the effect. Women living in Ontario who are not taking B vitamin supplements or probiotics and have no gastrointestinal issues may be suitable candidates. The trial aims to determine if probiotics can naturally enhance important vitamin levels in the body. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of probiotics' effects on vitamin levels.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take any B-vitamin supplements or probiotics during the study. If you're using these, you'll need to stop before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that probiotics have been used safely for many years. In studies, participants taking probiotics reported only minor issues like stomach cramps, nausea, and gas. These side effects are usually mild and uncommon.

Most probiotics are considered safe for healthy individuals. Although there have been some reports of serious problems, these are rare and typically occur in people with weakened immune systems.

Overall, most people tolerate probiotics well. The capsules used in the trial resemble many probiotic products already available in stores. As with any supplement, participants should monitor their body's reactions and inform the researchers of any concerns.12345

Why are researchers excited about this trial?

Most treatments for boosting vitamin levels typically involve dietary supplements or fortified foods. However, the probiotic capsule under study is unique because it uses live beneficial bacteria to potentially enhance vitamin absorption naturally in the gut. Researchers are excited about this approach since it taps into the body's natural processes, potentially offering a more sustainable and holistic method of increasing vitamin levels. Unlike traditional supplements, these probiotics could improve gut health while delivering vitamins, offering a dual benefit. The study is also exploring different doses, which might provide insights into optimizing effectiveness and safety.

What evidence suggests that this probiotic capsule is effective for influencing vitamin levels?

Research shows that probiotics can boost certain vitamin levels in the blood. Specifically, studies have found that taking probiotics can raise vitamin B12 and folate levels. However, strong evidence does not support an effect on vitamin B6 levels. Probiotics, which are live bacteria, can also support overall health, including the immune system. This support might help the body absorb and use vitamins more effectively. In this trial, participants will receive either a high dose or a low dose of a probiotic product in capsule form to evaluate its impact on vitamin levels.678910

Who Is on the Research Team?

KC

Kristin Connor, PhD

Principal Investigator

Carleton University

TV

Tim Van Mieghem, MD, PhD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for women aged 18-40 living in the Ottawa area who are not pregnant or breastfeeding, have no vitamin deficiencies, and do not have certain gut conditions. Participants must be able to attend study visits, provide samples, and follow instructions. Recent use of probiotics or B-vitamin supplements excludes participation.

Inclusion Criteria

Non-pregnant and non-lactating
I am biologically female.
I am between 18 and 40 years old.
See 4 more

Exclusion Criteria

Lactating, pregnant, or planning to become pregnant during the study
Not maintaining adequate birth control measures
Known sensitivity, intolerability, or allergy to any study products or their excipients
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a probiotic product for 4 weeks, with one group taking one capsule per day and another group taking two capsules per day. Activities include attending two in-person visits, providing blood and stool samples, completing online study diaries, questionnaires, and dietary assessments.

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of adverse events and nutrient levels.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Probiotic Capsule

Trial Overview

The study tests if taking a probiotic capsule daily for 4 weeks affects blood levels of vitamins B12, B6, and folate in healthy women. Two groups will take different doses (one vs two capsules per day). The design includes regular check-ins and sample collection.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Probiotic product (low dose)Experimental Treatment1 Intervention
Group II: Probiotic product (high dose)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carleton University

Lead Sponsor

Trials
3
Recruited
170+

Citations

Probiotic Supplementation and Micronutrient Status in Healthy ...

The results demonstrated that probiotics improved the levels of plasma vitamin B12 and folate and significantly decreased plasma Hcy levels. Some mechanisms ...

Probiotics - Health Professional Fact Sheet

Probiotics overview for health professionals. Research food and supplement sources, health effects, safety, selection, and use here.

A comprehensive review of probiotics and human health ...

Probiotics enhance immune system efficacy by augmenting the generation of antibodies and immunological cells. It combats illnesses and enhances immunity. Recent ...

Is There Evidence to Support Probiotic Use for Healthy ...

Probiotics can prevent urinary, vaginal, gastrointestinal, and respiratory infections, and improve risk factors associated with cardiovascular health or reduce ...

Probiotics Uses, Benefits & Dosage

... probiotics on vitamin B levels in healthy women. Vitamin B1 (thiamine) and B2 (riboflavin) levels were enhanced; however, no effect was observed on vitamin B6.

Risk and Safety of Probiotics - PMC - NIH

Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials.

Probiotics: Usefulness and Safety | NCCIH - NIH

It must be proven safe and effective for its intended use through clinical trials and be approved by the FDA before it can be sold. Learning About the ...

Regulatory Oversight and Safety of Probiotic Use

The probiotic drug must be proven safe and effective for its intended use before marketing (14). If a probiotic is intended for use as a dietary ...

Considerations for determining safety of probiotics: A USP ...

This review provides a helpful summary guide to global regulatory guidelines. We question the suitability of traditional animal toxicology studies.

Microbiological Safety of Probiotic Food Supplements - 2026

In conclusion, the tested probiotic food supplements are predominantly safe. The cases of non-compliance mainly affected quality management and ...