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Official title Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children
ClinicalTrials.gov ID: NCT07341750
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12. Healthy volunteers may be eligible.
You may be able to join 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...
- The participant or the participant's parents/guardian are willing and able to provide written assent and/or informed consent as appropriate.
You likely can't join 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...
- 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.
See the full eligibility 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).
- 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...
- 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...
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.