Actively Recruiting
A Randomized, Double-blind, Placebo Controlled Trial to Study the Safety and Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children
Led by Sanzyme Biologics Private Limited · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Bacillus coagulans SNZ 1969 on immune health in healthy children aged 6 to 12 years who attend school. The study aims to compare the probiotic to a placebo in reducing symptoms of upper respiratory tract infections (URTI) and gastrointestinal tract infections (GITI) during the 2025-2026 cold and flu season. The main focus is on measuring the incidence, duration, and severity of these infections using specific symptom questionnaires and immune biomarkers. Participants will be randomly assigned to receive either the Bacillus coagulans SNZ 1969 probiotic sachet containing 1 billion CFU/g or a placebo sachet daily for 84 days. The sachets are dissolved in water and taken before breakfast. The study includes a screening period, a 14-day run-in with symptom diaries, followed by baseline assessments and randomization. Remote visits occur on days 28 and 56, with the final clinic visit at day 84 involving sample collection and safety evaluations. Throughout the study, children and their caregivers will complete symptom diaries and questionnaires related to respiratory and gastrointestinal symptoms. Clinical assessments include measurements of vital signs, weight, height, and collection of blood, saliva, and stool samples to analyze immune responses and microbiome changes. Compliance with the study product is monitored by counting returned sachets. Safety and adverse events are closely tracked, and the study maintains strict confidentiality and data security. Participants are involved for approximately 84 days from baseline to the end of the study.
CONDITIONS
Brief Title
Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and complete questionnaires.
- The participant or their parents/guardian willing and able to provide written assent and/or informed consent as appropriate.
- Agrees to maintain current lifestyle habits throughout the study.
- Healthy as determined by medical history assessed by the Qualified Investigator.
You will not qualify if you...
- Individuals who are pregnant.
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of the investigational product or placebo ingredients.
- History or presence of clinically relevant cardiac, renal, hepatic, endocrine, respiratory, pulmonary, biliary, metabolic, haematologic, gastrointestinal, or pancreatic disorders.
- Confirmed history of COVID-19 infection in the 3 months prior to baseline.
- Immune dysfunction, autoimmune disease, immune compromised, or taking immunosuppressive medications.
- Severe environmental allergies requiring medical treatment or allergy shots.
- Major surgery in the past 3 months or planned surgery during the study.
- Cancer (except specific skin basal cell carcinoma cases or remission over five years).
- Asthma.
- Current use of prescribed or over-the-counter medications, supplements, or foods that may affect the study product.
- Participation in other clinical research studies 30 days prior to baseline.
- Cognitive or neurodevelopmental impairments affecting consent or assent.
- Any other condition or lifestyle factor that may affect study completion or safety as assessed by the Qualified Investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants complete study diaries including symptom questionnaires during the 14-day run-in period before starting the intervention.
No visits; daily diary completion
Duration - 84 days
Participants take the probiotic or placebo daily and complete symptom diaries; remote visits are conducted to review compliance and health status.
1 baseline visit (in-person) and 3 remote visits
Duration - 1 day
Participants return to the clinic for final assessments, return unused product, and submit completed diaries and biological samples.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
KGK Science Inc. 275 Dundas Street, Tower A Suite G025 London, ON N6B 3L1 Canada
London, Ontario, Canada, N6B 3L1
Actively Recruiting
Research Team
D
Dr DAVID CROWLEY, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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