Immune health in school-aged children Infections and Infestations
Conditions
Interventions
Each participant will be assigned a randomization code according to the order of the randomization list generated. Enrolled participants will be randomized to either of the study arms at Day 0.
Blo
Sponsors
Sanzyme Biologics Private Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 6 and 12 years of age at screening, inclusive 2. Children enrolled in and attending school in person at baseline 3. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic and remote visits 4. 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 5. The participant or the participant’s parents/guardian are willing and able to provide written assent and/or informed consent as appropriate 6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 7. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion criteria
Exclusion criteria: 1. Individuals who are pregnant 2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of the investigational product or placebo ingredients 3. 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 4. Confirmed history of COVID-19 infection in the 3 months prior to baseline 5. Immune dysfunction, autoimmune disease, immune compromised and/or taking an immunosuppressive medication, as assessed by the QI 6. Severe environmental allergies requiring medical or need for allergy shots, as assessed by the QI 7. 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 8. 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 9. Asthma, as assessed by the QI 10. 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 11. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 12. Participant or participant’s caregiver who are cognitively or neurodevelopmentally impaired affecting their ability to give informed consent and/or assent 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. URTI symptoms. The difference in incidence, duration, and severity (area-under-the-curve [AUC]) 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 [time frame: baseline to day 84] 2. Additional respiratory tract symptoms. The difference in incidence, duration, and severity (area-under-the-curve [AUC]) 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 [time frame: baseline to day 84] 3. GITI symptoms. The difference in incidence, duration, and severity (AUC) of GITI symptoms as assessed by the GITI Symptoms Questionnaire from baseline to day 84 between Bacillus coagulans SNZ 1969 and placebo [time frame: baseline to day 84] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in incidence, duration, and severity (AUC) of URTI as assessed by the CARIFS from baseline to days 28 and 56 between B. coagulans SNZ 1969 and placebo 2. The difference in incidence, duration, and severity (AUC) 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 3. The difference in incidence, duration, and severity (AUC) of GITI symptoms as assessed by the GITI Symptoms Questionnaire from baseline to days 28 and 56 between B. coagulans SNZ 1969 and placebo Additional secondary outcomes: 4. The difference between B. coagulans SNZ 1969 and placebo from baseline to days 28, 56, and 84 on: 4.1. Severity of cold/flu and GITI symptoms as assessed by total and individual daily symptom scores 4.2. Number of missed school days 4.3. Number of well days, related to the absence of cold/flu and GITI symptoms 4.4. Use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms 4.5. Total days of illness 5. Immunoglobulin and immune response biomarkers [time frame: baseline to day 84] 6. The difference in change between B. coagulans SNZ 1969 and placebo from baseline to day 84 on: 6.1. Saliva secretory immunoglobulin A (sIgA) concentrations 6.2. Serum levels of immunoglobulin A (IgA), G (IgG), E (IgE) and M (IgM) 6.3. Immune response biomarkers: CD14, CD163, CD40 (TNFRSF5), CRP (C-Reactive Protein), E-Selectin, Fas (TNFRSF6/Apo1), 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. 6.4. Microbiome as assessed by 16s rRNA fecal micr | — |
Countries
Canada
Contacts
Public ContactDavid Crowley
Outcome results
None listed