Could a daily probiotic keep school kids healthier this cold season?

NCT ID NCT07341750

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing whether a daily probiotic called Bacillus coagulans SNZ 1969 can help healthy children ages 6 to 12 have fewer and less severe colds, flu, and stomach bugs. One hundred kids will take either the probiotic or a placebo every day for 84 days during the cold and flu season. Researchers will track symptoms, immune markers in blood and saliva, and changes in gut bacteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bacillus coagulans SNZ 1969 (a probiotic)
What this could lead to
If it works, this could offer a simple, daily supplement to help healthy kids have fewer and milder colds and stomach bugs during the school year.
What could go wrong
This is a small, early-stage trial in healthy children, so results may not apply to everyone. Probiotics can sometimes cause mild digestive upset, and the benefit may be small or no different from placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females between 6 and 12 years of age at screening, inclusive. * Children enrolled in and attending school in person at baseline. * Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic and remote visits. * A care provider who can reliably bring the participant to study visits. The participant's primary caregiver must be willing and able to complete the questionnaires. * The participant or the participant's parents/guardian are willing and able to provide written assent and/or informed consent as appropriate. * Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study. * Healthy as determined by medical history as assessed by the Qualified Investigator (QI). Exclusion Criteria: * Individuals who are pregnant. * Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of the investigational product or placebo ingredients. * History or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), respiratory, pulmonary, biliary, metabolic, haematologic, gastrointestinal, or pancreatic disorders, that may affect participation or outcomes as assessed by the QI. * Confirmed history of COVID-19 infection in the 3 months prior to baseline. * Immune dysfunction, autoimmune disease, immune compromised and/or taking an immunosuppressive medication, as assessed by the QI. * Severe environmental allergies requiring medical or need for allergy shots, as assessed by the QI. * Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI. * Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable. * Asthma, as assessed by the QI. * Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and or safety of the investigational product. * Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI. * Participant or participant's caregiver who are cognitively or neurodevelopmentally impaired affecting their ability to give informed consent and/or assent. * Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • KGK Science Inc. 275 Dundas Street, Tower A Suite G025 London, ON N6B 3L1 Canada

    RECRUITING

    London, Ontario, N6B 3L1, Canada

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