Welcome!
We know you might have questions about the Sanzyme KIDS’ Immunity Study , our research study.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to Kids' Immunity Study
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Kids Immunity Study Introduction Video
2.Please Review the ICF Form And the ASSENT Form here.
Please review the Informed Consent Form & Assent Form for kids. You do not need to sign these copies but will be required to sign electronic copies when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
- The title of this study is: , “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”
- Many school-aged children get sick several times a year with upper respiratory infections, such as the common cold, or gastrointestinal infections like the stomach flu. Although children are among the most affected by these infections, there is a noticeable lack of options for natural health supplements that provide strong evidence for reducing the burden of cold and flu-like symptoms for children.
- Bacillus coagulans is a type of beneficial bacteria known as a probiotic. It has previously been shown to support immune health. The purpose of this study is to evaluate how Bacillus coagulans SNZ 1969 (B. coagulans) helps support the immune system in children attending school.
What is the study product? What is in it?
- If you are enrolled into the study, you will receive either the investigational product, Bacillus coagulans, or the placebo.
The investigational product contains:
Active Ingredient | Quantity (per dose) |
Bacillus coagulans SNZ 1969 | 1 billion CFU/g |
- Non-medicinal ingredients: Glucidex (maltodextrin), Magnesium stearate, Banana dry mix flavour.
The placebo contains:
- Non-medicinal ingredients: Glucidex (maltodextrin), Magnesium stearate, Banana dry mix flavour.
Are there any side effects?
- It is possible that your child could have problems or side effects from the study product that nobody knows about yet. There may be unknown risks with taking the study product. Potential side-effects of taking the study product may include:
- Abdominal discomfort (such as pain, nausea, changes in bowel habits)
- Dislike of taste
- Worsening of respiratory or gastrointestinal symptoms
How often and when does my child need to take study product?
Your child will start taking the study product on Day 1 (the day after Visit 2) and will continue taking it throughout the duration of the study.
- The content of one sachet will be completely dissolved in approximately 50 ml (about 3 tablespoons) of water, and your child will drink the entire mixture before breakfast.
- If any powder remains in the cup, add more water to dissolve it and have your child drink the remaining mixture
- If a dose is missed, they should take the missed dose as soon as you or your child remembers on the same day or the next day. They are not to take more than 2 sachets daily.
- Store the study product at room temperature and do not expose it to direct sunlight or heat.
- Save all unused and open study product packaging and return them to the clinic at Visit 5.
How/when can I find out if I got the investigational product or the placebo?
- This study is designed to be double-blinded. That means during the study neither you, your child, nor the study staff will know if your child is taking the study product or placebo.
- If you are interested in learning if your child received the product or placebo, we can let you know at a later date, when all participants have completed the study and statistical analysis of the data has been completed.
How long will the study last?
- Once your child has received the study product, participation will continue for approximately 84 days.
What does randomization mean?
- Randomized means that your child will be assigned by chance, like flipping a coin, to a study group (either the investigational product or the placebo).
- This is a double-blind study, so neither you, your child, nor the study doctor will know which group your child has been randomized to or which product your child will receive (investigational product or placebo). We will provide study products based on randomization.
Do I have to come into the clinic for any assessments?
Yes, Visit 1, 2, and 5 will require you and your child to come to the clinic. Visits 3 and 4 will be completed remotely.
Who/how do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your and your child’s time and participation in the study, you will be compensated a total of 1000$ if your child completes the entire study and all associated requirements.
How and when will I receive my compensation for participation?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
- Since your child is under the age of 18, Clincard will be assigned to the parent or legal guardian.
.
Is my participation confidential?
- Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
