Testing Probiotic formulation against a placebo for immunity
Official title: Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children
A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children
- 2 groups
- One site, in London
- Recruiting
Interventions
- Other intervention
Probiotic formulation
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.
- Other intervention
Placebo Control
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
KGK Science Inc. 275 Dundas Street, Tower A Suite G025 London, ON N6B 3L1 Canada
London, Ontario
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Males and females between 6 and 12 years of age at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, inclusive.
- +Children enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in and attending school in person at baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (QI).
Exclusion
- −Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of the investigational product or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → ingredients.
- −Severe environmental allergies requiring medical or need for allergy shots, as assessed by the QI.
- −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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- −Immune dysfunction, autoimmune disease, immune compromised and/or taking an immunosuppressive medication, as assessed by the QI.
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
- −Individuals who are pregnant.
- −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 upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Probiotic formulation.
Registry label: A: Probiotic Bacillus coagulans SNZ 1969 arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 6 years to 12 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around May 2026.
The main measurement is taken over: baselineBaselineYour starting measurements, taken before treatment begins.Read more → to day 84.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
URTI SYMPTOMS — measured over baselineBaselineYour starting measurements, taken before treatment begins.Read more → to day 84.
ADDITIONAL RESPIRATORY TRACT SYMPTOMS — measured over baseline to day 84.
GITI symptoms — measured over baseline to day 84.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07341750 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Probiotic formulationDietary 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.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Placebo ControlDietary 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.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 6 years to 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 6 years to 12 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: baselineBaselineYour starting measurements, taken before treatment begins.Read more → to day 84.
The study as a whole is currently expected to finish around 2026-05-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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. Review concomitant therapies (inclusive of previous vaccinations) and current health status 2. Assess inclusion and exclusion criteria 3. Review any pre-emergent AEs 4. Urine pregnancy test for potential volunteers that are of child-bearing potential 5. Vital sign measurements (BP and HR) 6. Weight and height measurements 7. Randomization of eligible participants 8. Collect blood samples for analysis of: 1. Quantibody® Human Immune Response Array 2. Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels 9. Collect saliva sample for the analysis of Salivary Ig A Levels 10. Collect stool samples for microbiome analysis 11. Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires 12. Dispense investigational product and instruct participants on use 13. Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires 14. Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit) 15. 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: 1. Return and review study diary 2. Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product 3. Review concomitant therapies and AEs 4. Vital sign measurements (BP and HR) 5. Weight and height measurements 6. Urine pregnancy test for participants that are of childbearing potential 7. Collect blood samples for the analysis of: 1. Quantibody® Human Immune Response Array 2. Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels 8. Collect saliva samples for the analysis of Salivary Ig A Levels 9. Collect stool samples for microbiome analysis 10. Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.