Probiotic for Immunity

(BC SNZ 1969 Trial)

Overseen By Dr DAVID CROWLEY, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sanzyme Biologics Private Limited

Must not be taking: Antibiotics, Probiotics, Immunosuppressants

Disqualifiers: Asthma, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Healthy children aged 6-12 attending school in person, who can complete study-related questionnaires and visits. They must maintain their current lifestyle habits during the trial. Children with respiratory or gastrointestinal conditions, taking immune-modifying drugs, antibiotics, probiotics including B. coagulans (unless after a washout period), or with any condition affecting safety or outcomes are excluded.

Inclusion Criteria

I agree to keep my lifestyle, including diet and exercise, the same during the study.

I am between 6 and 12 years old.

My child is currently going to school in person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants complete study diaries during the 14-day run-in period

2 weeks

Remote monitoring

Treatment

Participants take either probiotic Bacillus coagulans SNZ 1969 or a placebo every day for 84 days

12 weeks

3 visits (1 in-person, 2 remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bacillus Coagulans SNZ 1969

Trial Overview

The trial tests if Bacillus coagulans SNZ 1969 improves immune health in kids by reducing respiratory and gastrointestinal symptoms compared to a placebo. Over 84 days, it measures infection rates and severity using questionnaires and analyzes blood for immune markers, saliva for antibodies, and stool for microbiome changes.

How Is the Trial Designed?

Group I: Probiotic Bacillus coagulans SNZ 1969 arm Active Control 1 Intervention

Bacillus coagulans SNZ 1969 sachet containing 1 Billion CFU/g.

Group II: Placebo arm Placebo Group 1 Intervention

Placebo Ingredients: Glucidex (Maltodextrin), Magnesium Stearate, Banana dry mix flavour.

Who Is Running the Clinical Trial?

Sanzyme Biologics Private Limited

Lead Sponsor