💬In plain words
What the trial is, and whether it could suit you
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 sch
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
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