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| ID | Type | Description | Link |
|---|---|---|---|
| 79156228 | Other Identifier | ISRCTN, UK clinical trials registry |
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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:
Review concomitant therapies (inclusive of previous vaccinations) and current health status
Assess inclusion and exclusion criteria
Review any pre-emergent AEs
Urine pregnancy test for potential volunteers that are of child-bearing potential
Vital sign measurements (BP and HR)
Weight and height measurements
Randomization of eligible participants
Collect blood samples for analysis of:
Collect saliva sample for the analysis of Salivary Ig A Levels
Collect stool samples for microbiome analysis
Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
Dispense investigational product and instruct participants on use
Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit)
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:
Return and review study diary
Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product
Review concomitant therapies and AEs
Vital sign measurements (BP and HR)
Weight and height measurements
Urine pregnancy test for participants that are of childbearing potential
Collect blood samples for the analysis of:
Collect saliva samples for the analysis of Salivary Ig A Levels
Collect stool samples for microbiome analysis
Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
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. The planned sample size for this study is 100. In order to evaluate primary, secondary, and safety outcomes, study assessments will be conducted as per the Schedule of Assessments.
Screening (Day -45 to Day -15; Visit 1)*
* At the discretion of the Qualified Investigator, any participants falling outside of the screening window (Day -45 to Day -15) due to scheduling issues will be asked to repeat eligibility/screening procedures prior to randomization at baseline.
At screening, an ICF will be given to the potential volunteer. They will be required to read the information and will be given the opportunity to seek more information if needed or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the caregiver and volunteer will sign the consent and assent forms as applicable and receive a duplicate of the signed copy. Once consent has been obtained, screening will proceed. Each volunteer will be assigned a screening number to be entered in the screening and enrollment log.
Screening assessments include:
Run-in (Day -14 to Day -1):
Participants will complete the study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires during the 14-day run-in period.
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:
Review concomitant therapies (inclusive of previous vaccinations) and current health status
Assess inclusion and exclusion criteria
Review any pre-emergent AEs
Urine pregnancy test for potential volunteers that are of child-bearing potential
Vital sign measurements (BP and HR)
Weight and height measurements
Randomization of eligible participants
Collect blood samples for analysis of:
Collect saliva sample for the analysis of Salivary Ig A Levels
Collect stool samples for microbiome analysis
Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
Dispense investigational product and instruct participants on use
Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit)
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) Visit 3 (Day 28 ± 2 days) Participants will attend remotely for Visit 3 assessments with completed study diaries inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires.
Visit 3 assessments include:
Visit 4 assessments include:
The next visit will be scheduled for Day 84 (± 2 days). Visit 5 - 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:
Return and review study diary
Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product
Review concomitant therapies and AEs
Vital sign measurements (BP and HR)
Weight and height measurements
Urine pregnancy test for participants that are of childbearing potential
Collect blood samples for the analysis of:
Collect saliva samples for the analysis of Salivary Ig A Levels
Collect stool samples for microbiome analysis
Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires.
This study will be conducted with the highest respect for the individual participants (i.e., participants) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP. Written consent documents will embody the elements of informed consent as described in the declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The ICF describes the planned and permitted uses, transfers, and disclosures of the volunteer's personal and personal health information for purposes of conducting the study. The ICF further explains the nature of the study, its objectives, and potential risks and benefits, as well as the date informed consent is obtained. The ICF will detail the requirements of the volunteer and the fact that he or she is free to withdraw at any time without giving a reason and without prejudice to his or her further medical care.
Study monitoring:
Source documents will be reviewed to ensure that all items have been completed and that the data provided are accurate and obtained in the manner specified in the protocol. The participant files will be reviewed to confirm that:
The Qualified Investigator will permit study-related monitoring, audits, IRB/IEC review, and regulatory inspections and will allow direct access to source data and documents for these purposes. Data required for the analysis will be acquired from source documentation (including laboratory reports) and captured through electronic data capture (EDC) case report forms specifically designed for this study.
A password-protected user ID is created giving access to the delegated study personnel. The data management personnel designs the database, and once the database is finalized study-specific Data Management Plan is generated.
The standard data validation and edit checks are performed by designing study-specific rules and restrictions defined in the eCRF. The discrepancies will be queried and managed. Data sets will be created, queried, and exported during and at the end of the study.For Statistical analysis, the data management personnel provides a validated locked blinded database to the Statistician to perform the analysis.
High safety standards for the transfer and storage of study data are guaranteed by the use of technologies such as password protection, firewalls, and periodic backup to protect stored data. All study data is archived for a period not less than 15 years from the date of completion of the study in accordance with Health Canada regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Bacillus coagulans SNZ 1969 arm | Active Comparator | Bacillus coagulans SNZ 1969 sachet containing 1 Billion CFU/g. |
|
| Placebo arm | Placebo Comparator | Placebo Ingredients: Glucidex (Maltodextrin), Magnesium Stearate, Banana dry mix flavour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS) | The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) of URTI as assessed by the CARIFS from baseline to days 28 and 56 between B 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulins | Saliva secretory immunoglobulin A (sIgA) concentrations; Serum levels of Immunoglobulin A (IgA), G (IgG), E (IgE) and M (IgM) | Baseline to day 84 |
| Immune response biomarkers | Immune related protein serum levels (pg/mL) of - CD14, CD163, CD40 (TNFRSF5), CRP (C-Reactive Protein), E-Selectin, Fas (TNFRSF6/Apo-1), Fas Ligand (TNFSF6), GCSF, ICAM-1 (CD54), IL-1 alpha (IL-1 F1), IL-1 beta (IL-1 F2), IL-1 R4 (ST2), IL-10, IL-12 p70, IL-13, IL18, IL-2, IL-2 R alpha, IL-4, IL-6, IL-8 (CXCL8), Lipocalin-2 (NGAL), MCP-1 (CCL2), MCP-2 (CCL8), MIF, MIP-1 alpha (CCL3), MIP-1 beta (CCL4), Osteopontin (SPP1), PAI-1, Platelet Factor 4 (CXCL4), Procalcitonin, RAGE, Resistin, Thrombomodulin, TNF alpha, TREM-1, Troponin I, uPAR, VCAM-1 (CD106), VEGF-A. The units of measurement for all the Immune Biomarkers are in pg/mL). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr DAVID CROWLEY, MD | Contact | 519-438-9374 | dcrowley@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. 275 Dundas Street, Tower A Suite G025 London, ON N6B 3L1 Canada | Recruiting | London | Ontario | N6B 3L1 | Canada |
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| 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. |
|
| baseline to days 28 and 56 |
| 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 days 28 and 56 between B coagulans SNZ 1969 and placebo. Additional Respiratory Tract symptoms Scale: Usually 0 (None) to 3 (Severe) with higher scores indicating greater severity. | Baseline to days 28 and 56 |
| 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 days 28 and 56 between B. 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 days 28 and 56 |
| Total and individual daily symptoms | The difference between B. coagulans SNZ 1969 and placebo on the severity of cold/flu and GITI symptoms as assessed by total and individual daily symptoms | baseline to days 28, 56, and 84 |
| Missed school days | The difference between B. coagulans SNZ 1969 and placebo on the number of missed school days | baseline to days 28, 56, and 84 |
| Number of well days | The difference between B. coagulans SNZ 1969 and placebo from on the number of well days, related to the absence of cold/flu and GITI symptoms | baseline to days 28, 56, and 84 |
| Use of cold/flu medications | The difference between B. coagulans SNZ 1969 and placebo on the use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms | baseline to days 28, 56, and 84 |
| Total days of illness | The difference between B. coagulans SNZ 1969 and placebo on the total days of illness | baseline to days 28, 56, and 84 |
| baseline to day 84 |
| Fecal microbiome analysis | Microbiome as assessed by 16s rRNA fecal microbiome analysis | baseline to day 84 |
| Safety and Tolerability - Incidence of post-emergent adverse events (AE). | Number of participants with Incidence of post-emergent adverse events (AE) | through study completion upto Day 84 |
| Changes in Vital signs (Blood Pressure) | Number of participants with clinically relevant changes in vital signs - Blood Pressure [Systolic blood pressure (SBP)/Diastolic blood pressure (DBP)] with units in millimeters of mercury (mmHg) after supplementation | through study completion upto Day 84 |
| Changes in Vital signs (Heart Rate) | Number of participants with clinically relevant changes in vital signs - Heart rate (HR) with units in bpm (beats per minute) after supplementation | through study completion upto Day 84 |