Clinical Results: Safety and Efficacy

More than 30 studies have been performed to confirm the safety and efficacy of Bacillus subtilis DE111. A full genome sequencing confirmed the strain contained no plasmids, antibiotic resistant or deleterious genes. The genome sequence of DE111 has been uploaded to GenBank, the National Institutes of Health genetic sequence database.

Multiple human clinical studies support DE111’s benefits to digestive and immune health, and Deerland is committed to continuously conducting additional studies. All studies are IRB-approved, double-blind, randomized and placebo controlled.

 

Human Clinical Study: Supports Digestion

A clinical study evaluating the effect of DE111 on digestive health resulted in a significant influence on gut microflora measured prior to and after capsule consumption (5 billion CFU). Fecal samples showed an increase in the levels of B. subtilis and Bifidobacterium (good bacteria), and a slight decrease in levels of E. coli (bad bacteria). DE111 was also able to maintain healthy levels of cholesterol, glucose and triglycerides, indicating that DE111 supports the normal breakdown of complex carbohydrates, sugars and fats. View Published Study – DE111

Human Clinical Study: Supports Regularity

A clinical study showed a reduction of alternating constipation and diarrhea for the participants taking DE111 (1 billion CFU) when compared to participants taking the placebo. The proportion of normal stools (types 3 and 4) increased from 54% to 64% in the DE111 group, while the proportion of normal stools decreased from 56% to 48% in the placebo group. In male participants specifically, the proportion of normal stools increased from 56% to 80%. In addition, a significant difference between the DE111 and placebo groups was observed in regards to normal and non-normal stool proportions in the 30+ age group. View Published Study – DE111

 


 

Human Clinical Study: Sports Performance, Body Composition and Recovery

In a study involving female collegiate athletes during offseason training, researchers found that DE111 (1 billion CFU), in conjunction with adequate post-workout nutrition, can improve body composition and indices of athletic performance. The results of the study showed that compared to the placebo, the probiotic DE111 produced statistically significantly improvements in the reduction of body fat percentage, and a strong trend indicating improved performance of the deadlift exercise.
View Published Study – DE111

In a study involving male collegiate athletes during offseason training, researchers found that DE111 (1 billion CFU), in conjunction with adequate post-workout nutrition, can promote tissue recovery and reduce likelihood of injury. The results of the study showed that compared to the placebo, the probiotic DE111 produced a statistically significantly reduction of tumor necrosis factor alpha (TNA-α).
View Published Study – DE111

Human Clinical Study: Cardiovascular Health

In a study involving 43 participants aged 18 to 65, researchers found that B. subtilis DE111 supplementation of 1 billion CFU per day resulted in significant reduction in total cholesterol and non-HDL cholesterol relative to baseline measures. The team also observed a strong trend toward reduction in LDL cholesterol, as well as improvement in endothelial function; reactive hyperemia index (RHI), an indicator of blood flow and heart health, increased by 9.14%.
View Published Study – DE111

Human Clinical Study: Children’s Microbiome & Immune Health

In a study involving 91 children aged 2 to 6, researchers found that daily consumption of the probiotic strain Bacillus subtilis DE111 positively modulated the gut microbiome profile without changing the overall microbiome equilibrium. After 8 weeks of daily probiotic consumption at 1 billion CFU, the researchers observed an increase in alpha-diversity at the phylum level, suggesting an expanded functional diversity of the microbiome compared to that of the children in the placebo group. Specifically, there were 9 differentially abundant taxa at the genus level found in the probiotic group, six (of the phylum bacteroidetes) grew in abundance while three (of the phylum firmicutes) were reduced. The six taxa of bacteroidetes that flourished are involved in immune regulation and reduction of inflammation. This modulation of the firmicutes/bacteroidetes ratio of the microbiome in children taking B. subtilis DE111 is a positive indication for healthy gut function.
View Published Study – DE111

In a study involving 81 children aged 2 to 6, researchers found that that daily consumption of the probiotic strain Bacillus subtilis DE111 supported a healthy gastrointestinal tract with a reduced duration of vomiting, hard stools and overall gastrointestinal discomfort.
View Published Study – DE111

Human Clinical Study: Immune Health

In a study involving 44 participants aged 20-62, researchers observed after four weeks of daily consumption of the probiotic DE111 at 1 billion CFU, a significant decrease in the basal levels of several immune cell populations, including CD3+ T cells, cytotoxic T cells and NKT cells. Moreover, the probiotic group showed an increased capacity for immune response in cells stimulated by an induced inflammation. The results suggests that DE111 may modulate the immune system through action on both innate (rapid response) and adaptive (slow response) immune cell types.
View Published Study – DE111