Bacillus coagulans SNZ 1969 for immune health in school-aged children

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

Healthy children aged 6–12 who attend school will be assigned to receive either a Bacillus coagulans SNZ 1969 probiotic formulation or a matching placebo for 84 days during the 2025–2026 cold and flu season. The primary outcomes compare incidence, duration, and severity of upper respiratory and gastrointestinal symptoms between groups using the CARIFS and a GITI symptoms questionnaire. Secondary measures include immunoglobulin levels, other immune biomarkers, and changes in the fecal microbiome. Strict inclusion and exclusion criteria—including washout from other probiotics, antibiotics, or immune-modulating products and exclusion of children with relevant chronic respiratory or gastrointestinal conditions—are used to reduce confounding.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: David Crowley, MD — KGK Science Inc.
• Study coordinator: Dr DAVID CROWLEY, MD
• Email: dcrowley@kgkscience.com
• Phone: 519-438-9374

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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.