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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- URTI SYMPTOMS
研究概览
简要总结
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:
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Review concomitant therapies (inclusive of previous vaccinations) and current health status
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Assess inclusion and exclusion criteria
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Review any pre-emergent AEs
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Urine pregnancy test for potential volunteers that are of child-bearing potential
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Vital sign measurements (BP and HR)
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Weight and height measurements
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Randomization of eligible participants
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Collect blood samples for analysis of:
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Quantibody® Human Immune Response Array
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Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
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Collect saliva sample for the analysis of Salivary Ig A Levels
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Collect stool samples for microbiome analysis
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Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
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Dispense investigational product and instruct participants on use
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Dispense study diary inclusive of the CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
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Dispense stool collection kit for microbiome analysis for Visit 5 (End of Study visit)
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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:
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Return and review study diary
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Return unused investigational product in the original packaging and remnants and calculate compliance by counting the returned unused investigational product
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Review concomitant therapies and AEs
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Vital sign measurements (BP and HR)
-
Weight and height measurements
-
Urine pregnancy test for participants that are of childbearing potential
-
Collect blood samples for the analysis of:
-
Quantibody® Human Immune Response Array
-
Immunoglobulins A (IgA), G (IgG), E (IgE) and M (IgM) serum levels
-
Collect saliva samples for the analysis of Salivary Ig A Levels
-
Collect stool samples for microbiome analysis
-
Review completed study diaries including CARIFS, Additional respiratory tract symptoms, and GITI symptoms questionnaires
详细描述
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. The planned sample size for this study is 100. In order to evaluate primary, secondary, and safety outcomes, study assessments will be conducted as per the Schedule of Assessments.
Screening (Day -45 to Day -15; Visit 1)*
* At the discretion of the Qualified Investigator, any participants falling outside of the screening window (Day -45 to Day -15) due to scheduling issues will be asked to repeat eligibility/screening procedures prior to randomization at baseline.
At screening, an ICF will be given to the potential volunteer. They will be required to read the information and will be given the opportunity to seek more information if needed or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the caregiver and volunteer will sign the consent and assent forms as applicable and receive a duplicate of the signed copy. Once consent has been obtained, screening will proceed. Each volunteer will be assigned a screening number to be entered in the screening and enrollment log.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Probiotic Bacillus coagulans SNZ 1969 arm
Bacillus coagulans SNZ 1969 sachet containing 1 Billion CFU/g.
干预措施: Probiotic formulation (Dietary Supplement)
Placebo arm
Placebo Ingredients: Glucidex (Maltodextrin), Magnesium Stearate, Banana dry mix flavour.
干预措施: Placebo Control (Dietary Supplement)
结局指标
主要结局
URTI SYMPTOMS
时间窗: baseline to day 84
The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) 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. CARIFS Scoring: 18 items, each scored 0 (none) to 3 (severe), yielding a total score from 0 to 54 (higher score = worse illness).
ADDITIONAL RESPIRATORY TRACT SYMPTOMS
时间窗: baseline to day 84
The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) 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. Additional Respiratory Tract symptoms Scale: Usually 0 (None) to 3 (Severe) with higher scores indicating greater severity.
GITI symptoms
时间窗: baseline to day 84
The difference in incidence - Proportion (%), duration - days, and severity (area-under-the-curve (AUC) - score days) of GITI symptoms as assessed by the GITI Symptoms Questionnaire from baseline to day 84 between Bacillus coagulans SNZ 1969 and placebo. GITI Symptom questionnaire is rated on a three-point Likert-type scale ranging from 0 to 2, with a higher score signifying more severe GI symptoms.
次要结局
- Canadian Acute Respiratory Illness and Flu Scale (CARIFS)(baseline to days 28 and 56)
- Additional Respiratory tract symptoms(Baseline to days 28 and 56)
- GITI Symptoms(Baseline to days 28 and 56)
- Total and individual daily symptoms(baseline to days 28, 56, and 84)
- Missed school days(baseline to days 28, 56, and 84)
- Number of well days(baseline to days 28, 56, and 84)
- Use of cold/flu medications(baseline to days 28, 56, and 84)
- Total days of illness(baseline to days 28, 56, and 84)