DE111® Bacillus subtilis scientific studies

A healthy gut microbiome is crucial for a strong immune system, especially in children whose microbiota are particularly vulnerable to a heightened risk of gastrointestinal or respiratory infections. This is why nourishing the gut with a diverse diet rich in fruits, vegetables, fibre, and antioxidants is so vital. 

However, incorporating fermented foods and beneficial bacterial strains can also significantly contribute to a more resilient immune system. But not all strains are created equally, which means their efficacy can be questionable. 

This is why we only ever use scientifically studied beneficial bacterial strain, DE111®, AKA Bacillus subtilis. Backed by two gold-standard published studies, B. subtilis is scientifically proven to positively impact the gut microbiome when taken daily, with immediate effects reported.

A naturally occurring, viable and effective spore-forming bacterial strain, it’s also known as "hay bacillus” and found in a variety of natural environments, including earth-rich soils, hay, air, water, and in both human and animal intestines. 

DE111® conforms to EU regulations and has been tested by third parties for contaminants, pesticides and traceability of GMOs (Genetically Modified Organisms). It’s safe for children, with genome sequencing confirming no antibiotic resistance genes. 

Its demonstrable efficacy can be attributed to its ability to resist and survive the stomach's acidic environment, which means it importantly reaches the gut alive. Unlike many bacterial strains, it’s also heat stable, so it can survive manufacturing processes and be stored up to 24 months without refrigeration. Reported results include:

• Immediate impact on microbial diversity
• Reduced pro-inflammatory bacteria
• Increased beneficial bacteria
• Reduced vomiting, loose stools & gastrointestinal discomfort in illness
• A decrease in the Firmicutes/Bacteroidetes ratio - linked to improved metabolic health & immune function.

For a deeper insight into the potential of this incredible bacterial strain, read the two studies in detail here…

 

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STUDY 1

Paytuví-Gallart, A., Sanseverino, W. and Winger, AM. (2020), Daily intake of probiotic strain Bacillus subtilis DE111 supports a healthy microbiome in children attending day-care, Beneficial Microbes; 11(7): 611-620. 

Link to study HERE

 

How was it conducted?

Well-controlled and ethically conducted, this randomised, double-blind, placebo-controlled trial:

• Involved 102 healthy children aged 2–6 who attend daycare
• Assigned each child either DE111®, i.e. 1 billion Colony Forming Units (CFU), or a placebo, to be taken once daily for eight weeks.
• Analysed stool samples for gut microbiome changes.

 

What benefits were they seeking?

Researchers not only wanted to explore the effects of the friendly bacterial strain, Bacillus subtilis, on microbiome composition, but also demonstrate that it’s just as effective and safe as other commonly studied forms of friendly bacteria on the market, such as Lactobacillus acidophilus, Bifidobacterium and Saccharomyces.

 

What did they find?

Results indicate that DE111® has a significant impact on the overall microbiome, supporting the growth of the microbes involved in contributing to a reduction in inflammation and gastrointestinal disturbances:

 

IMPACT ON MICROBIAL DIVERSITY

Differences in alpha diversity, i.e. microbial diversity, were noted right from baseline to week 8.

 

AN ABUNDANCE OF BENEFICIAL BACTERIA

These included an increase in the level of Bacteroides (P<0.05) and Alistipes (P<0.01), both of which are associated with reduced inflammation.

 

REDUCED PRO-INFLAMMATORY BACTERIA

A decrease in the presence of less helpful bacteria was noted, namely Streptococcaceae (P<0.01), Eisenbergiella (P<0.001) and Lactobacillales (P<0.01).

 

DECREASED FIRMICUTES/BACTEROIDETES RATIO

A decrease of <p<0.05 was observed. This bacterial strain’s ratio is linked to improved metabolic health and immune function.

 

The study concluded that the changes in both abundance and diversity of microbiota have implications for immune regulation, which in turn can help support a more resilient immune system and overall health. 

 

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STUDY 2

Slivnik, M. et al. (2020), Effect of daily Bacillus subtilis DE111® intake on gastrointestinal health and respiratory infections in children attending day-care: A randomised, parallel, double-blind, placebo-controlled study, Journal of Probiotics and Health; 8(4):225. 

Link to study HERE

 

How was it conducted?

Another randomised, double-blind, placebo-controlled study, this trial entailed:

• 102 preschool children (aged 2–6) in daycare
• Each taking DE111® (1 billion CFU daily) or a placebo, once daily for eight weeks
• Participants’ diaries compiled by parents and evaluated by investigators to follow the incidence and duration of indicators of gastrointestinal health and respiratory infections, as well as any adverse events.
• Collecting saliva samples at baseline and completion of the intervention to measure secretory Immunoglobulin A (sIgA) levels, an antibody which has a protective action on the immune system.

 

What benefits were they seeking?

The incidence of infections requiring medical attention is twice as high among children in daycare, with gastroenteritis (diarrhoea and vomiting) and flu-like illnesses being the most common. 

For most parents who wish to minimise antibiotic use, live microorganisms, specifically probiotics, can provide a more natural and equally effective alternative. With this in mind, researchers evaluated both the safety and efficacy of Bacillus subtilis or DE111®, in gastrointestinal & respiratory infections, as well as its impact on children’s health.

 

What did they find?

Notable results were recorded: 

 

SIGNIFICANTLY REDUCED VOMITING

As few as two days were reported with DE111® versus 14 days on the placebo (P=0.045).

 

REDUCED DIARRHOEA

Hard stools were reported from 0 days when taking Bacillus subtilis vs 15 days on the placebo (P=0.044).

 

GASTROINTESTINAL DISCOMFORT WAS ALMOST HALVED

With candidates reporting improvement at 18 days of taking DE111®. While improvement was only seen at 48 days with the placebo (P=0.0499). Symptoms associated with digestive discomfort were also greatly improved.

 

While no difference in respiratory infections was observed (41.3% probiotic vs 36.2% placebo, p=0.60), the study concluded that B. subtilis DE111®  is a safe and effective option for supporting a healthy gastrointestinal tract, reducing the duration of vomiting, while supporting healthy bowel movement and improving the gastrointestinal discomfort commonly experienced in gastroenteritis and flu-like illness.