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

NCT07341750 | Recruiting

• 2 other identifiers: 25SACCP0179156228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Review concomitant therapies (inclusive of previous vaccinations) and current health status
2. 2.Assess inclusion and exclusion criteria
3. 3.Review any pre-emergent AEs
4. 4.Urine pregnancy test for potential volunteers that are of child-bearing potential
5. 5.Vital sign measurements (BP and HR)
6. 6.Weight and height measurements
7. 7.Randomization of eligible participants
8. 8.Collect blood samples for analysis of:
9. 9.Quantibody® Human Immune Response Array
10. 10.Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
11. 11.Collect saliva sample for the analysis of Salivary Ig A Levels
12. 12.Collect stool samples for microbiome analysis
13. 13.Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
14. 14.Dispense investigational product and instruct participants on use
15. 15.Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
16. 16.Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit)
17. 17.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).
18. 18.Return and review study diary
19. 19.Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product
20. 20.Review concomitant therapies and AEs
21. 21.Vital sign measurements (BP and HR)
22. 22.Weight and height measurements
23. 23.Urine pregnancy test for participants that are of childbearing potential
24. 24.Collect blood samples for the analysis of:
25. 25.Quantibody® Human Immune Response Array
26. 26.Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
27. 27.Collect saliva samples for the analysis of Salivary Ig A Levels
28. 28.Collect stool samples for microbiome analysis
29. 29.Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires

Conditions

Immunity

Keywords

Probiotic immune health; Bacillus coagulans; Bacillus coagulans SNZ 1969

Outcome Measures

Primary Outcomes (3)

• URTI SYMPTOMS

  The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) of URTI as assessed by the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) from baseline to day 84 between Bacillus coagulans SNZ 1969 and Placebo. CARIFS Scoring: 18 items, each scored 0 (none) to 3 (severe), yielding a total score from 0 to 54 (higher score = worse illness).

  baseline to day 84

• ADDITIONAL RESPIRATORY TRACT SYMPTOMS

  The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) of Additional Respiratory Tract Symptoms as assessed by Additional Respiratory Tract Symptoms questionnare from baseline to day 84 between Bacillus coagulans SNZ 1969 and placebo. Additional Respiratory Tract symptoms Scale: Usually 0 (None) to 3 (Severe) with higher scores indicating greater severity.

  baseline to day 84

• GITI symptoms

  The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) of GITI symptoms as assessed by the GITI Symptoms Questionnaire from baseline to day 84 between Bacillus coagulans SNZ 1969 and placebo. GITI Symptom questionnaire is rated on a three-point Likert-type scale ranging from 0 to 2, with a higher score signifying more severe GI symptoms.

  baseline to day 84

Secondary Outcomes (8)

• Canadian Acute Respiratory Illness and Flu Scale (CARIFS)

  baseline to days 28 and 56

• Additional Respiratory tract symptoms

  Baseline to days 28 and 56

• GITI Symptoms

  Baseline to days 28 and 56

• Total and individual daily symptoms

  baseline to days 28, 56, and 84

• Missed school days

  baseline to days 28, 56, and 84

Other Outcomes (6)

• Immunoglobulins

  Baseline to day 84

• Immune response biomarkers

  baseline to day 84

• Fecal microbiome analysis

  baseline to day 84

Study Arms (2)

Probiotic Bacillus coagulans SNZ 1969 arm

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic formulation

Placebo arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Control

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

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.

Probiotic Bacillus coagulans SNZ 1969 arm

Placebo Control DIETARY_SUPPLEMENT

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.

Placebo arm

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanzyme Biologics Private Limited: lead

Study Sites (1)

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

London, Ontario, N6B 3L1, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr DAVID CROWLEY, MD

CONTACT

519-438-9374; dcrowley@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 14, 2026
• Study Start: November 5, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)