Probiotic for Immunity

(BC SNZ 1969 Trial)

Overseen By Dr DAVID CROWLEY, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sanzyme Biologics Private Limited

Must not be taking: Antibiotics, Probiotics, Immunosuppressants

Disqualifiers: Asthma, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a probiotic called Bacillus coagulans SNZ 1969 to determine if it boosts immune health in school-aged children. Researchers aim to discover whether it reduces symptoms of colds and stomach bugs compared to a placebo. The trial seeks children aged 6-12 who are generally healthy and not taking other probiotics or immune-modulating medications. Participants will take either the probiotic or a placebo daily for about three months to observe the effects. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the potential health benefits of probiotics in children.

Will I have to stop taking my current medications?

Participants must stop taking immune modulating medications, antibiotics, products containing B. coagulans, or any other probiotic supplements before joining the trial. The protocol mentions a 'washout' period (time without taking certain medications) for these substances.

Is there any evidence suggesting that Bacillus coagulans SNZ 1969 is likely to be safe for children?

Research has shown that Bacillus coagulans SNZ 1969 is generally recognized as safe (GRAS) for use in foods, meaning it is considered safe to eat under normal conditions. It has been used as a probiotic, a supplement containing beneficial bacteria that support the body, particularly the gut.

No major reports of serious side effects have emerged from using this probiotic, indicating it is well-tolerated by most people. However, individual responses can vary, and some might experience mild side effects like an upset stomach or gas.

For children with specific health concerns, consulting a healthcare provider before participating in a clinical trial with this probiotic is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which often includes lifestyle changes and dietary supplements, Bacillus Coagulans SNZ 1969 is a probiotic that specifically targets and enhances immune function. Researchers are excited about this treatment because it uses a unique strain of bacteria known for its potential to boost immunity by promoting gut health. Additionally, its delivery method as a sachet containing 1 billion CFU/g makes it easy to incorporate into daily routines. This approach could offer a natural and convenient way to support the body's defenses compared to traditional methods.

What evidence suggests that Bacillus coagulans SNZ 1969 might be an effective treatment for immune health in children?

Research shows that Bacillus coagulans SNZ 1969, the probiotic under study in this trial, can improve immune health. Studies have found that this probiotic significantly increases the activity of natural killer (NK) cells, which fight infections. It also boosts the production of IgA, an antibody crucial for the immune function of the body's mucous membranes. This suggests that taking B. coagulans might help the body better protect against respiratory and digestive infections. Although most research has focused on adults, these findings indicate potential benefits for children as well. Participants in this trial will receive either Bacillus coagulans SNZ 1969 or a placebo. ^{4 6 7 8 9}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Healthy children aged 6-12 attending school in person, who can complete study-related questionnaires and visits. They must maintain their current lifestyle habits during the trial. Children with respiratory or gastrointestinal conditions, taking immune-modifying drugs, antibiotics, probiotics including B. coagulans (unless after a washout period), or with any condition affecting safety or outcomes are excluded.

Inclusion Criteria

I agree to keep my lifestyle, including diet and exercise, the same during the study.

I am between 6 and 12 years old.

My child is currently going to school in person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants complete study diaries during the 14-day run-in period

2 weeks

Remote monitoring

Treatment

Participants take either probiotic Bacillus coagulans SNZ 1969 or a placebo every day for 84 days

12 weeks

3 visits (1 in-person, 2 remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bacillus Coagulans SNZ 1969

Trial Overview

The trial tests if Bacillus coagulans SNZ 1969 improves immune health in kids by reducing respiratory and gastrointestinal symptoms compared to a placebo. Over 84 days, it measures infection rates and severity using questionnaires and analyzes blood for immune markers, saliva for antibodies, and stool for microbiome changes.

How Is the Trial Designed?

Group I: Probiotic Bacillus coagulans SNZ 1969 arm Active Control 1 Intervention

Bacillus coagulans SNZ 1969 sachet containing 1 Billion CFU/g.

Group II: Placebo arm Placebo Group 1 Intervention

Placebo Ingredients: Glucidex (Maltodextrin), Magnesium Stearate, Banana dry mix flavour.

Who Is Running the Clinical Trial?

Sanzyme Biologics Private Limited

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07341750

Effects of Bacillus Coagulans SNZ 1969 on Immune Health ...

The current study will examine the efficacy of Bacillus coagulans SNZ 1969 (B. coagulans) on immune health in children attending school. The ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12624130/

Immunomodulatory Effects of Probiotic Bacillus coagulans ...

Conclusions: B. coagulans SNZ 1969® supplementation significantly enhanced NK cell activity and mucosal IgA production in adults, suggesting its ...

3.

isrctn.com

isrctn.com/ISRCTN79156228

Effects of Bacillus coagulans SNZ 1969 on immune health - In ...

The purpose of this study is to evaluate how Bacillus coagulans SNZ 1969 (B. coagulans) helps support the immune system in children attending school. Who ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41262831/

Immunomodulatory Effects of Bacillus coagulans SNZ 1969

Conclusions: B. coagulans SNZ 1969® supplementation significantly enhanced NK cell activity and mucosal IgA production in adults, suggesting its ...

5.

jcdr.net

jcdr.net/articles/PDF/19825/73063_CE[Ra1]_F(IS)_QC_Ref_Pat(PS_IS)_PF1(AG_OM)_PFA(AG_KM)_PN(KM).pdf

Safety and Efficacy of Bacillus coagulans SNZ 1969® ...

While probiotics have shown potential in improving gut health and immune responses, their efficacy in malnourished children, particularly those ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0273230019303022

Safety evaluation of Bacillus coagulans SNZ 1969 in Wistar ...

B. coagulans SNZ 1969 has GRAS (Generally Recognized As Safe) status for use as a probiotic in foods (US FDA number GRN-597). The present ...

7.

fda.gov

fda.gov/files/food/published/GRAS-Notice-000691--Bacillus-coagulans-SANK-70258-spore-preparation.pdf

GRAS Notice 691, Bacillus coagulans SANK 70258 spore ...

GRAS Notice: Bacillus coagulans SNZ 1969 spores preparation. (GRN ... coagulans SANK 70258 and these data can be used to support the safety ofB ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31751640/

Safety evaluation of Bacillus coagulans SNZ 1969 in Wistar ...

B. coagulans SNZ 1969 has GRAS (Generally Recognized As Safe) status for use as a probiotic in foods (US FDA number GRN-597).

9.

downloads.regulations.gov

downloads.regulations.gov/FDA-2025-N-1928-0014/attachment_1.pdf

GRAS Notice (GRN) 1263, Bacillus coagulans

The safety and efficacy ofNHPs and their health claims must be supported by proper evidence. Evidence may include clinical trial data or ...