Nanoflora by BioPharma Scientific

POSSIBLY EFFECTIVE

• Antibiotic-associated diarrhea. Oral Bacillus subtilis seems to be beneficial for preventing antibiotic-associated diarrhea. Details: Clinical research in patients given antibiotics for at least 5 days shows that taking a total of 2 billion colony-forming units (CFUs) of B. subtilis B2335 alone or with Bacillus licheniformis B2336 twice daily results in around 8% or 10% of patients, respectively, developing antibiotic-associated diarrhea compared with around 32% of those taking placebo. In order to prevent antibiotic-associated diarrhea, four patients need to be treated with Bacillus subtilis. Nausea, vomiting, abdominal pain, and bloating were also prevented. The probiotics were started one day prior to antibiotic treatment and continued for 7 days after completion (110854).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Small clinical studies suggest that oral Bacillus subtilis may not improve athletic performance. Details: Two small clinical trials in offseason college athletes undergoing a resistance training program show that taking B. subtilis DE111 (Deerland Enzymes, Kennesaw, GA, USA) does not improve measures of athletic performance, including speed, strength, or agility, when compared with placebo (110850,110855). In one trial, female athletes took B. subtilis DE111 5 billion colony forming units (CFUs) daily for 10 weeks (110850). In the other, male athletes took one billion CFUs daily for 12 weeks (110855). Larger clinical trials in these and other athletic populations are still needed.
• Atopic dermatitis (eczema). Although there has been interest in using oral Bacillus subtilis for atopic dermatitis, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Cirrhosis. Although there has been interest in using oral Bacillus subtilis for cirrhosis, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Clostridioides difficile infection. Although there has been interest in using oral Bacillus subtilis for C. difficile prevention and treatment, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Constipation. Although there has been interest in using oral Bacillus subtilis for preventing constipation in infants, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Critical illness (trauma). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in critically ill adults receiving ventilation shows that receiving B. subtilis and Enterococcus faecalis (Medilac-S) three times daily through a nasogastric feeding tube for up to 14 days results in microbiologically confirmed VAP in around 36% of individuals compared with around 50% of patients not receiving these probiotics, and the mean time to develop VAP was increased by almost 3 days. These findings suggest that seven patients need to be treated to prevent one episode of VAP. However, there was no effect on the incidence of clinically suspected VAP or length of hospital stay. All patients were also given standard preventive strategies (110851).
• Diabetes. Although there has been interest in using oral Bacillus subtilis for diabetes, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Diarrhea. It is unclear if oral Bacillus subtilis is beneficial for patients with chronic loose stools. Details: A small clinical study in adults with chronic loose stools shows that taking B. subtilis C-3102 2.2 billion colony-forming units (CFUs) daily for 8 weeks modestly decreases stool frequency and improves stool form when compared with placebo. There was no difference in stool water content or other gastrointestinal symptoms (110836). The effect of B. subtilis on symptoms of chronic diarrhea is unclear from this study.
• Dyslipidemia. Although there has been interest in using oral Bacillus subtilis for dyslipidemia, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Dyspepsia. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some studies have used B. subtilis in combination with other probiotics. In adults with functional dyspepsia, a small clinical study shows that taking a combination of B. subtilis MY02 and Bacillus coagulans MY01 as 1.25 billion colony-forming units (CFUs) each twice daily for 8 weeks improves postprandial distress scores of at least 0.7 in 48% of patients, compared with only 20% of those taking placebo (107611). Also, a small study in adults with non-specific gastrointestinal discomfort shows that taking a specific combination supplement (SNZ TriBac, Sanzyme Biologics) containing B. subtilis SNZ 1972, Bacillus coagulans SNZ 1969, and Bacillus clausii SNZ 1971, 2 billion CFUs daily for 30 days, decreases self-reported symptoms of burping, belching, and sour taste when compared with placebo. However, there was no effect on symptoms such as heartburn, nausea, and passing gas (104231). It is unclear if these effects are due to B. subtilis, other ingredients, or the combinations.
• Flatulence. It is unclear if oral Bacillus subtilis is beneficial for patients with flatulence. Details: A small clinical study in healthy adult shows that taking B. subtilis BS50 2 billion colony-forming units (CFUs) once daily for 6 weeks does not affect the proportion of patients with flatulence when compared with placebo. However, the proportion of patients with an improvement in burping and bloating was more than doubled when compared with placebo (110841).
• Helicobacter pylori. Although there has been interest in using oral Bacillus subtilis for Helicobacter pylori infection, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Hypertension. Although there has been interest in using oral Bacillus subtilis for hypertension, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Irritable bowel syndrome (IBS). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in patients with IBS with diarrhea shows that taking B. subtilis 100 million colony-forming units (CFUs), along with Streptococcus faecium 900 million CFUs and tianeptine 37.5 mg three times daily, improves overall IBS symptoms to the same degree as taking the same doses of B. subtilis and Streptococcus faecium in combination with amitriptyline 10 mg daily for 4 weeks (100805). The same dose of B. subtilis was used by all patients; the effect of B. subtilis alone is unclear.
• Necrotizing enterocolitis (NEC). Although there has been interest in using oral Bacillus subtilis for preventing NEC in infants, there is insufficient reliable information about the clinical or adverse effects of B. subtilis for this purpose.
• Neonatal jaundice. Although there has been interest in using oral Bacillus subtilis for preventing neonatal jaundice, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Pancreatitis. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients hospitalized with mild acute pancreatitis shows that taking a combination of B. subtilis and Enterococcus faecium reduces hospital length of stay by approximately 0.7 days when compared with taking placebo. There were also modest reductions in time to relief of abdominal symptoms and time to oral feeding (110849). The dose of B. subtilis is unclear from this study. Also, it is unclear if these effects are due to B. subtilis, Enterococcus faecium, or the combination.
• Prematurity. Oral or parenteral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in premature infants shows that receiving B. subtilis, along with Enterococcus faecium and multivitamins (Medilac-Vita) twice daily with mosapride 0.5 mg three times daily modestly increases the decline in serum levels of total bilirubin and the fading of jaundice compared with mosapride in combination with Saccharomyces boulardii or routine care only. Growth rate, symptoms of abdominal discomfort, gastrointestinal motility, rates of feeding intolerance, and incidence rates of complications such as sepsis and necrotizing enterocolitis, were all improved in the groups receiving mosapride and probiotics compared with routine care only (110852). The dose of B. subtilis is unclear from this study. Also, it is unclear if these effects are due to B. subtilis, other ingredients, or the combinations.
• Sepsis. Although there has been interest in using oral Bacillus subtilis for preventing sepsis in infants, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Ulcerative colitis. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of over 50 clinical studies in patients with ulcerative colitis shows that taking a specific product containing B. subtilis R0179 and Enterococcus faecium R0026 (Medilac-S), 3 billion colony-forming units (CFUs) daily of for 4-96 weeks, as adjunctive therapy with oral aminosalicylates, usually sulfasalazine or mesalazine, increases the likelihood of inducing clinical remission by 21% when compared with the conventional therapy alone. The proportion of patients reporting symptoms such as abdominal pain and diarrhea was reduced by 40% to 53%. Most individual studies showed that these probiotics reduced the likelihood of symptom recurrence; however, a pooled analysis for this outcome could not be conducted (110853). It is unclear if any effects are due to B. subtilis, Enterococcus faecium, or the combination.
• Ventilator-associated pneumonia (VAP). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in critically ill adults receiving ventilation shows that receiving B. subtilis and Enterococcus faecalis (Medilac-S) three times daily through a nasogastric feeding tube for up to 14 days results in microbiologically confirmed VAP in around 36% of individuals compared with around 50% of patients not receiving these probiotics, and the mean time to develop VAP was increased by almost 3 days. These findings suggest that seven patients need to be treated to prevent one episode of VAP. However, there was no effect on the incidence of clinically suspected VAP or length of hospital stay. All patients were also given standard preventive strategies (110851). More evidence is needed to rate Bacillus subtilis for these uses.

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POSSIBLY SAFE ...when taken orally and appropriately. Some strains of B. subtilis are considered "generally regarded as safe" (GRAS) for use in food (110841). Bacillus subtilis has been used with apparent safety in clinical studies. B. subtilis strains BS50, B2335, CU1, MB40, MY02, or R0179 have been used with apparent safety in doses of 2-10 billion colony forming units (CFUs) daily for 2-8 weeks (107611,110841,110843,110846,110847,110848,110854,110859). One specific product, B. subtilis DE111, has been used with apparent safety in doses of one billion CFUs daily for 12 weeks or 5 billion CFUs daily for 10 weeks (110850). Another specific product (Medilac-S), containing a combination of B. subtilis R0179 and Enterococcus faecalis, has been used with apparent safety in doses providing up to 300 million CFUs of B. subtilis daily for up to 96 weeks (110853,110860).

CHILDREN:
There is insufficient reliable information available about the safety of Bacillus subtilis in children of any age. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

PREGNANCY AND LACTATION:
Insufficient reliable information available when used in doses higher than those found in foods; avoid using.

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ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking Bacillus subtilis with antibiotic drugs might decrease the effectiveness of B. subtilis.  Details Since B. subtilis preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and B. subtilis preparations by at least 2 hours.

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General ...Orally, Bacillus subtilis seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. subtilis may cause bacteremia in certain patients.

Dermatologic ...Orally, itching and redness were reported rarely (110848).

Gastrointestinal ...Orally, diarrhea has been reported rarely (110846).

Immunologic ...There are cases of Bacillus subtilis var. natto bacteremia and meningitis in patients with frequent consumption of natto, soybeans fermented with B. subtilis var. natto (110844,110862). A 70-year-old female recovered from bacteremia after this consumption was stopped and she was treated with vancomycin. It was hypothesized that this infection was due to an immunocompromised state related to age, type 2 diabetes, kidney failure, multiple myeloma, coronavirus disease 2019 (COVID-19), and treatment with immunosuppressive therapy (110844). In a 67-year-old female, bacterial entry was suspected to be related to erosion of her esophagus (110862).
There have been other rare cases of bacteremia or infections due to B. subtilis. These cases are unlikely to be related to intake or supplementation but to an immunocompromised state and/or introduction of bacteria to the body via non-oral routes. Cases of bacteremia include a newborn infant with sepsis, an adult with esophageal perforation, and a patient undergoing bone marrow transplantation subjected to contaminated materials (110834,110837,110840). There is also a case of cholangitis in a 15-year-old child with a recent kidney transplant related to polycystic kidney disease (110838).

Neurologic/CNS ...Orally, one case of headache was reported in a clinical trial (110847).

Pulmonary/Respiratory ...Orally, two cases of nasal obstruction were reported in a clinical trial (110847).

Other ...Orally, an acute episode of mild pain was reported in a clinical trial (110847).

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