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

A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children

This trial will try whether daily Bacillus coagulans SNZ 1969 reduces respiratory and gastrointestinal symptoms and changes immune markers in healthy 6–12-year-old children.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Sanzyme Biologics Private Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT07341750 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy boys and girls aged 6–12 who attend school in person, can comply with study visits and diaries, and are free from recent probiotic, antibiotic, or immune-modulating medication use are ideal candidates.

Not a fit: Children with chronic respiratory, pulmonary, or gastrointestinal diseases, those currently taking antibiotics or immune-modulating therapies, or those who have not completed the required probiotic washout are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the probiotic could reduce how often, how long, or how severe colds and stomach infections are in school-aged children and improve some immune markers.

How similar studies have performed: Some probiotic and Bacillus-strain studies have shown modest reductions in respiratory or gastrointestinal symptoms in children, but results are mixed and the specific SNZ 1969 strain has limited large-scale pediatric data.

Eligibility criteria

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 this trial is running

London, Ontario

• 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

Conditions Immunity; Probiotic immune health; Bacillus coagulans; Bacillus coagulans SNZ 1969