Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children

Summary

The goal of this clinical trial is to investigate the safety and efficacy of Bacillus coagulans SNZ 1969 on immune health in healthy school-aged children in terms of reduction of respiratory symptoms, gastrointestinal symptoms, immunoglobulins, immune biomarkers and fecal microbiome changes.

The current study will examine the efficacy of Bacillus coagulans SNZ 1969 (B. coagulans) on immune health in children attending school. The primary outcome will assess the difference between the investigational product and placebo from baseline to day 84 in incidence, duration, and severity of Upper Respiratory Tract Infection (URTI) and Gastrointestinal Tract Infection (GITI) symptoms. This will be assessed by use of the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) and a GITI symptoms questionnaire.

Enrolled participants will include children 6-12 years of age currently attending school during the 2025-2026 cold and flu season to allow for adequate exposure to URTI or GITI pathogens. To avoid confounding effects of pre-existing medical conditions children presenting with a history or presence of a clinically relevant respiratory, pulmonary, or gastrointestinal condition will be excluded at the discretion of the Qualified Investigator. Furthermore, participants consuming immune modulating medications, antibiotics, products containing B. coagulans, or any other probiotic supplement will be excluded unless they have undergone the specified washout. The strict eligibility criteria is designed to reduce confounders on immune health affecting both upper respiratory tract infections and gastrointestinal tract infection symptoms. Children presenting with any other medical condition or lifestyle factor which may affect the safety of their participation or study outcomes will also be excluded.

Each participant will be assigned a randomization code according to the order of the randomization list generated. Enrolled participants will be randomized to the different study arms at Day 0. Participants will take either probiotic Bacillus coagulans SNZ 1969 or a placebo every day for 84 days.

Day 0 (Baseline, Visit 2) Eligible volunteers will return to the clinic for baseline assessments with collected stool and saliva samples.

Baseline (Day 0) assessments include:

1. Review concomitant therapies (inclusive of previous vaccinations) and current health status
2. Assess inclusion and exclusion criteria
3. Review any pre-emergent AEs
4. Urine pregnancy test for potential volunteers that are of child-bearing potential
5. Vital sign measurements (BP and HR)
6. Weight and height measurements
7. Randomization of eligible participants
8. Collect blood samples for analysis of:

1. Quantibody® Human Immune Response Array
2. Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
9. Collect saliva sample for the analysis of Salivary Ig A Levels
10. Collect stool samples for microbiome analysis
11. Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
12. Dispense investigational product and instruct participants on use
13. Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
14. Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit)
15. Dispense saliva collection kit for Visit 5 (End of Study visit) The next visit will be conducted remotely and scheduled for Day 28 (± 2 days) and Day 56 (± 2 days).

End of Study (Day 84 ± 2 days):

Participants will return to the clinic for end of study assessments, with unused investigational product, completed study diaries (inclusive of the CARIFs, Additional respiratory tract symptoms, and GITI symptoms questionnaires), and stool and saliva samples.

Visit 5 assessments include:

1. Return and review study diary
2. Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product
3. Review concomitant therapies and AEs
4. Vital sign measurements (BP and HR)
5. Weight and height measurements
6. Urine pregnancy test for participants that are of childbearing potential
7. Collect blood samples for the analysis of:

1. Quantibody® Human Immune Response Array
2. Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
8. Collect saliva samples for the analysis of Salivary Ig A Levels
9. Collect stool samples for microbiome analysis
10. Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires

Conditions

• Immunity

Interventions

DIETARY_SUPPLEMENT

Probiotic formulation

Bacillus coagulans SNZ 1969 1 Billion CFU/g in sachet form with non-medicinal ingredients: Glucidex (maltodextrin), Magnesium stearate, Banana dry mix flavour. Participants will be instructed to fully consume 1 sachet containing 1 Billion CFU/g completely dissolved in approximately 50 ml of water before breakfast starting on Day 1 and throughout the duration of the study.

DIETARY_SUPPLEMENT

Placebo Control

Placebo Ingredients: Glucidex (Maltodextrin), Magnesium Stearate, Banana dry mix flavour. Participants will be instructed to fully consume 1 sachet completely dissolved in approximately 50 ml of water before breakfast starting on Day 1 and throughout the duration of the study.

Sponsors & Collaborators

• Sanzyme Biologics Private Limited

  lead INDUSTRY

Principal Investigators

• David Crowley, MD · KGK Science Inc.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-05

Primary Completion

2026-04-30

Completion

2026-05-31

Countries

• Canada

Study Locations