What is Bacillus coagulans

Bacillus coagulans is a type of “beneficial” bacteria or probiotic bacteria and it is used similarly to lactobacillus and other probiotics. Bacillus coagulans has been called ‘the king of probiotics’ due to its high stability in the gastrointestinal tract, non-toxic action, as well as high but not yet fully understood pharmacological activity ¹. Probiotics are defined as “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host” ². According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, nutritional supplements, including probiotics, are considered food rather than drugs ³. They are not regulated for clinical application, which results in so-called health claims rather than disease-based claims. The DSHEA requires that dietary supplements meet current good manufacturing practices, but unfortunately, there are substandard products that meet this threshold. Government regulation of probiotics in the United States is complex. Depending on a probiotic product’s intended use, the U.S. Food and Drug Administration (FDA) might regulate it as a dietary supplement, a food ingredient, or a drug. Dietary supplements are regulated by the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition ⁴. If the probiotics are considered to be drugs for therapeutic purposes, then the product is regulated by the U.S. Food and Drug Administration using Current Good Manufacturing Practices and Investigational New Drug approval processes ⁵.  Many probiotics are sold as dietary supplements, which don’t require FDA approval before they are marketed. Dietary supplement labels may make claims about how the product affects the structure or function of the body without FDA approval, but they aren’t allowed to make health claims, such as saying the supplement lowers your risk of getting a disease, without the FDA’s consent. If a probiotic is going to be marketed as a drug for treatment of a disease or disorder, it has to meet stricter requirements. It must be proven safe and effective for its intended use through clinical trials and be approved by the FDA before it can be sold.

Bacillus coagulans is relatively resistant to extreme temperatures, gastric juice, and bile salts and can survive in the gut for several days without repeated oral consumption ⁶. In the duodenum, the spores of Bacillus coagulans can germinate into vegetative bacteria showing probiotic activity; then they are excreted from the body without alteration of the individual human microflora’s composition ⁷. These characteristics make Bacillus coagulans a relatively ideal probiotic due to its stability and long survivability when consumed ⁸. Evidence suggests that Bacillus coagulans can decrease the occurrence of abdominal pain and bloating in subjects with inflammatory bowel disease (IBD) and can ameliorate the symptoms of irritable bowel syndrome (IBS) or functional bowel disorder ⁹. The term “functional bowel disorder” (FBD) refers to various gastrointestinal symptoms, such as abdominal pain/discomfort, bloating/distension, and diarrhea/constipation, for which there is no obvious organic cause. functional bowel disorder can lead to impaired social function and a diminished quality of life ⁸. The precise pathophysiology of functional bowel disorder remains unknown. functional bowel disorder continues to pose a therapeutic challenge in that the currently available therapies only provide symptomatic relief, but do not alter the natural history of the disorder. Antispasmodics may improve functional bowel disorder symptoms by relaxing gut smooth muscles, providing benefits for abdominal pain and global assessment ¹⁰. However, dose-dependent adverse events, including constipation, fatigue, dry mouth, dizziness, and blurred vision may occur, especially in the elderly.

Bacillus coagulans produces lactic acid and is often misclassified as lactobacillus. In fact, some commercial products containing Bacillus coagulans are marketed as Lactobacillus sporogenes. Unlike lactic acid bacteria such as lactobacillus or bifidobacteria, Bacillus coagulans forms spores. Spores are an important factor in telling Bacillus coagulans apart from other lactic acid bacteria. Worldwide, there are numerous strains of probiotics used in dietary supplements and foods, but most are unstable at room temperature and need to be freeze dried or encapsulated via special processes to remain viable during manufacturing, storage, and exposure to stomach acid and bile ¹¹. Consequently, for most probiotics, only a very small percentage of the starting material is actually viable at the end of shelf life. Bacillus coagulans is a notable exception which, due to its sporulated form, survives without special handling and proliferates in the gastrointestinal environment ¹². Due to Bacillus coagulans excellent stability, it has been widely used in medicine, food and chemical industry ¹³. Recent studies have shown that Bacillus coagulans has therapeutic effects on intestinal diseases, such as acute diarrhea, irritable bowel syndrome (IBS), antibiotic-related diarrhea, constipation and colitis via modulation of the microbiota composition, host immunity and metabolism ¹³. Additionally, toxicological experiments and a large number of clinical observations have showed that Bacillus coagulans is safe and has no effect of mutagenicity, teratogenicity or genotoxicity ¹³.

Bacillus coagulans vs Lactobacillus

Bacillus coagulans forms spores. Spores are an important factor in telling Bacillus coagulans apart from other lactic acid bacteria (Lactobacillus). Bacillus coagulans is relatively resistant to extreme temperatures, gastric juice, and bile salts and can survive in the gut for several days without repeated oral consumption ⁶. In the duodenum, the spores of Bacillus coagulans can germinate into vegetative bacteria showing probiotic activity; then they are excreted from the body without alteration of the individual human microflora’s composition ⁷. These characteristics make Bacillus coagulans a relatively ideal probiotic due to its stability and long survivability when consumed ⁸.

How does Bacillus coagulans work?

There is not enough information to know how Bacillus coagulans might work for medical purposes. Some of the pharmacological effects of Bacillus coagulans remain poorly understood. Some research shows that Bacillus coagulans might increase immune system function and decrease harmful bacteria. In particular, it concerns its strong immunomodulatory effect, antiviral activity and stimulation of the normal intestinal microflora’s rapid recovery ¹⁴. Experimental and clinical studies have confirmed the immunomodulatory effect of the Bacillus coagulans. For instance, when the blood cells in healthy human volunteers were exposed to adenovirus and influenza A, the administration of probiotic significantly increased the production of the markers of CD3-CD69 + cells, IL-6 and IL-8 interleukins, γ-interferon and TNF-α ¹⁵.

Subsequent to oral administration, Bacillus coagulans arrives in the stomach in its spore form, where it is exposed to the stomach’s churning action and acidic pH that causes the spore coating to absorb water, swell, and begin the germination process ¹². Upon arrival in the duodenum, Bacillus coagulans spores germinate and multiply rapidly. Estimates suggest the average duration of time between oral dosing and germination is 4-6 hours ¹⁶, with approximately 85 percent of the starting material reaching the intestinal tract. After germination, Bacillus coagulans is metabolically active in the intestines, producing levorotatory L(+)lactic acid, the form most readily metabolized in glycogen synthesis by the body (i.e., the isomeric form that would not be expected to contribute to metabolic acidosis) ¹⁷. Bacillus coagulans is considered a transient colonizing probiotic, indicating it takes up only temporary residence in the human intestines ¹⁸. Spores of Bacillus coagulans are excreted slowly via the feces for approximately seven days after discontinuation of administration ¹⁸.

Bacillus coagulans has also been shown in vitro to produce bacteriocins ¹⁸, bacteriocin-like substances,9and short-chain fatty acids that nourish the colonic mucosa ¹⁹. Bacteriocins are peptides produced by some strains of bacteria that inhibit the growth of other bacteria. Coagulin, a bacteriocin-like substance ²⁰ and lactosporin, a unique antimicrobial protein with a lipid moiety ²¹, have been isolated from Bacillus coagulans and demonstrate significant antibacterial activity.

In vitro bioassays have also shown components of the cell wall and supernatant of certain strains of Bacillus coagulans influence gut inflammation via cytokine modulation, inhibition of reactive oxygen species, and enhanced phagocytosis ²². Research in humans has also shown Bacillus coagulans GBI-30-6086 increased tumor necrosis factor-alpha (TNF-α) response to adenovirus by 250 percent over baseline after 30 days of treatment ¹². A 1,709-per-cent increase in the TNF-α response to influenza A was also noted, but no effect was observed for other strains of influenza ²³. Antifungal activity by Bacillus coagulans has also been demonstrated in vitroagainst Fusarium species, although the mechanism behind this has not been determined ²⁴.

Bacillus coagulans possesses significant beta-galactosidase (lactase) activity in vitro and may also have lactic acid dehydrogenase activity, thereby enhancing the digestibility of lactose in those who are lactose intolerant ²⁵. Bacillus coagulans assimilates and incorporates cholesterol into its cellular structure, binds cholesterol in the gut, and may inhibit the cholesterol-producing enzyme 3-hydroxy-3-methylglutaryl-coenzyme reductase (HMG-CoA reductase) ²⁶.

Bacillus coagulans benefits

When probiotics are consumed in sufficient quantities, they offer health benefits in preventing and treating a diverse spectrum of gastrointestinal disorders, such as antibiotic-associated diarrhea (including Clostridium difficile-associated), small bowel bacterial overgrowth, infectious diarrhea (including traveller’s diarrhea and viral diarrhea), inflammatory bowel disease, and irritable bowel syndrome (IBS) ²⁷. Although the complete mechanism of action probiotics have on the body is not fully understood, there have been certain notable findings in the past. Research has found probiotics to enhance the immune system, playing a role in both innate and adaptive immunity and increasing the overall efficiency; probiotics enhance gut health, including competition for limited nutrients, inhibiting the epithelial invasion of pathogens, and augmenting the growth of nonpathogenic bacteria ²⁸. Furthermore, research shows that probiotics carry many anti-inflammatory effects. They act as a regulatory substance for the immune system, helping to sustain homeostasis when it comes to inflammatory and anti-inflammatory responses ²⁹. Probiotics can decrease immune-mediated activation, modulate epithelial immune functions ³⁰ and modify neural traffic between the gut and the central nervous system to alter gas transit and visceral hypersensitivity ³¹. Probiotics have also been implicated in impacting both the enteric and central nervous systems, thereby decreasing notions of pain through the activation of opioid and endocannabinoid receptors ³².

Bacillus coagulans have been examined for their effectiveness in treating infectious or inflammatory bowel diseases (IBD). A double-blind, placebo-controlled randomized trial was conducted with healthy volunteers in Japan, wherein Bacillus coagulans in soy pulp powder was used to improve bowel movements and stool characteristics ³³. When constipated patients with functional bowel disorder consumed Bacillus coagulans (Lilac LAB, 1 × 10⁸ colony forming units [CFUs]) once per day for 2 weeks, the average scores of the self-reported scores for fecal size, sensation of incomplete evacuation, and defecation frequency significantly improved, compared to that observed in the placebo group ³³. However, in non-functionally constipated patients, no significant improvements were observed, compared to the placebo group. In another study ⁸, the constipation-dominant functional bowel disorder group achieved greater improvements than did the diarrhea-dominant group in terms of the feeling during defecation (2.6–3.6 vs 2.5–3.1) and normalization of defecation style (50% vs 7.1%) at day 28. These improvements were maintained from days 14 to 28, irrespective of their being constipation-dominant or diarrhea-dominant. How long the improvement can be maintained? In one study with adult irritable bowel syndrome (IBS) patients treated with Bacillus coagulans three times a day for 12 consecutive weeks, which showed Bacillus coagulans can improve abdominal pain and diarrhea in IBS patients and maintain up to 12 months ³⁴.

Bacillus coagulans is possibly effective for a long-term disorder of the large intestines that causes stomach pain (irritable bowel syndrome or IBS). Clinical research shows that taking Bacillus coagulans daily for 56-90 days improves quality of life and decreases bloating, vomiting, abdominal pain, and the number of bowel movements in people with diarrhea-predominant IBS. Other clinical research shows that taking a specific combination product (Colinox, DMG Italia SRL) containing Bacillus coagulans and simethicone three times daily for 4 weeks improves bloating and discomfort in people with IBS.

Bacillus coagulans showed its efficacy against neonatal rotavirus-induced diarrhea ³⁵; it also significantly weakened the rheumatoid arthritis’ symptoms intensity ³⁶. These effects can be related to a direct immunomodulatory action of Bacillus coagulans spore forms ³⁷. During test tube experiments the metabolites and cell walls of Bacillus coagulans intensified the phagocytosis (the polymorphonuclear leucocytes’ population increased, including the phagocytic cells), the migration of polymorphonuclear leucocytes (spontaneous migration and the migration caused by the bacterial peptide f-MLP), and the inhibited migration induced by pro-inflammatory interleukin-8 and leukotriene LTB-4 ³⁸. Both components of Bacillus coagulans induced the expression of killer cells (CD 69 marker) and affected the production of cytokines: inhibited IL-2 production, enhanced production of IL-4, IL-10, and, especially, IL-6. These effects were aimed at the stimulation of the B lymphocytes’ proliferation and differentiation, and at the anti-inflammatory action. In addition, the probiotic significantly increased the gamma-interferon production ³⁹. The experiments showed the similar species Bacillus subtilis spores’ ability to penetrate into the Peyer’s patches and interact with the gut-associated lymphoid system, and to accumulate in macrophages and germinate therein ⁴⁰. Although the spores’ germination within macrophages is not terminated by the formation of vegetative bacteria, the immune system interprets such spores’ behavior as an invasion ³⁶.

There is insufficient evidence to rate effectiveness of Bacillus coagulans for:

• Liver scarring (cirrhosis). People with liver cirrhosis are more likely to develop an infection called spontaneous bacterial peritonitis or SBP. Early research shows that taking a combination probiotic containing Bacillus coagulans and other bacteria three times daily, along with the drug norfloxacin, does not decrease a person’s risk of developing spontaneous bacterial peritonitis.
• Diarrhea. Early research in babies 6-24 months of age with diarrhea shows that taking Bacillus coagulans for up to 5 days does not alleviate diarrhea. However taking Bacillus coagulans does improve diarrhea and stomach pain in adults.
• Diarrhea caused by rotavirus. Early research in newborn babies shows that taking Bacillus coagulans daily for one year decreases the child’s risk of developing rotavirus diarrhea.
• Gas (flatulence). Early evidence in people who have gas after eating shows that taking a specific combination supplement containing Bacillus coagulans and a blend of enzymes daily for 4 weeks does not improve bloating or gas.
• Excessive growth of bacteria in the small intestines. Early evidence shows that using a specific probiotic product (Lactol, Bioplus Life Sciences Pvt. Ltd.) containing Bacillus coagulans and fructo-oligosaccharides daily for 15 days of every month for 6 months might modestly decrease stomach pain and gas in people with potentially harmful bacteria in the intestine.
• Rheumatoid arthritis (RA). Early research shows that taking Bacillus coagulans daily for 60 days in addition to normal treatment can reduce pain, but does not reduce the number of painful or swollen joints in people with RA. Bacillus coagulans also does not improve the ability to perform activities of daily living in people with RA.
• A serious intestinal disease in premature infants (necrotizing enterocolitis or NEC). Babies that are born very early or with a very low weight are at a higher risk of developing a serious infection in the intestines called necrotizing enterocolitis. Early research in these babies shows that taking Bacillus coagulans daily until leaving the hospital does not prevent necrotizing enterocolitis or death. However, taking Bacillus coagulans does increase the number of babies that are able to tolerate food.
• Cancer prevention.
• Infection of the gastrointestinal tract by a bacteria called Clostridium difficile.
• Digestion problems.
• A digestive tract infection that can lead to ulcers (Helicobacter pylori or H. pylori).
• Immune system strengthening.
• Long-term swelling (inflammation) in the digestive tract (inflammatory bowel disease or IBD).

Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) is a chronic gastrointestinal condition of multi-factorial etiology, presenting with episodic abdominal bloating, pain, diarrhea and/or constipation. Management of irritable bowel symptoms can be challenging and may significantly impact the patient’s quality of life. Because probiotics have the ability to improve bowel health, strains of Bacillus coagulans have been studied as a therapy for IBS in two randomized, double-blind clinical trials.

In one eight-week study ⁴¹, 52 men and women (ages 30-67) with diarrhea-predominant IBS (IBS-D) were randomized to receive one capsule daily of Bacillus coagulans with two billion colony forming units (CFUs) (n=26) or identically appear-ing placebo (microcrystalline cellulose; n=26). Patients were monitored at baseline and daily for eight weeks and were assessed for compliance, frequency of bowel movements, abdominal pain, distention, flatulence, and urgency. The average number of bowel movements decreased significantly in the Bacillus coagulans group when compared to placebo (p=0.042); differences between treatment and placebo groups for other parameters did not reach statistical significance ⁴¹.

In the second study ⁴², 44 subjects with IBS-D (82 percent women; average age 48 years) were randomized to either the Bacillus coagulans (n=22) or placebo (n=22) group. Those in the treatment group received one capsule daily of Bacillus coagulanscontaining 800 million CFUs and those in the placebo group received an identical-appearing capsule. Subjects were assessed at baseline and treated for eight weeks with three follow-up visits. Within-group improvements over baseline frequency, abdominal pain, and bloating scores reached statistical significance for each week of treatment in the Bacillus coagulans group (p<0.01), but only at weeks 6 and 8 for the placebo group. Between-group statistical comparison was not conducted.No significant adverse events were reported. Data from both studies suggest Bacillus coagulans may be an effective therapy for decreas-ing bowel movement frequency, abdominal pain, and bloating in patients with IBS ⁴².

Antibiotic-associated diarrhea

In a 2007 systematic review of the literature including 10 randomized trials and 1,986 children ⁴³, Bacillus coagulans was shown to be among the most promising probiotics for preventing antibiotic-associated diarrhea. In a multi-center, randomized, double-blind, placebo-controlled trial, the effect of Bacillus coagulans on antibiotic-associated diarrhea was investigated in 98 children. Subjects were divided into placebo and treatment groups, with those in the treatment group given a Bacillus coagulans-fructo-oligosaccharide preparation for 10 days. At the end of the treatment period, only 29 percent of children in the Bacillus coagulans group continued to experience diarrhea compared to 62 percent in the placebo group. The average duration of diarrhea was also significantly shorter in the treatment group (0.7 days) when compared to the placebo group (1.6 days) ⁴⁴.

Neonatal and infant diarrhea

Research conducted in India has shown Bacillus coagulans is effective in decreasing frequency and duration of neonatal diarrhea caused by acute rotavirus infection ⁴⁵. Administration of 100 million CFUs of Bacillus coagulans or placebo daily for one year to 112 newborns resulted in statistically significant decreases in number of diarrhea episodes and duration of each episode – 3.6 days in treatment group versus 6.8 days in placebo group. Conversely, two more recent studies demonstrated Bacillus coagulans administration had no impact on necrotizing enterocolitis or rate of death in very low birth weight neonates ⁴⁶ or in older infants (6-24 months) with diarrhea and dehydration ⁴⁷.

Dysbiosis

Dysbiosis is a condition in which the gut bacteria become imbalanced, leading to a wide range of digestive disturbances including bloating, diarrhea, constipation, and stomach cramps, among others. In laboratory animals with bacterial dysbiosis, Bacillus coagulans supplementation inhibits growth of pathogenic microorganisms and results in renewal of desirable obligate gastrointestinal organisms to normal levels. Reports suggest that supplementation produces a rapid resolution of acute gastrointestinal infection induced by pathogenic bacteria in animals ⁴⁸. It has also been reported that Bacillus coagulans treatment in conjunction with traditional probiotics results in 20- to 30-percent higher treatment efficacy in humans with bacterial dysbiosis than traditional probiotics such as Lactobacillus acidophilus or Bifidobacteria alone ⁴⁹. It should be noted that English full-text versions of these studies ⁴⁹, ⁵⁰ were not available, so detailed information is lacking.

Flatulence

Flatulence is a buildup of gas in the digestive system that can lead to abdominal discomfort. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the effects of Bacillus coagulans on post-prandial gas-related intestinal symptoms. Sixty-one adults (average age 36.5 years) were randomized to receive two billion CFUs Bacillus coagulans or placebo daily for four weeks. Subjects were evaluated at baseline, two, and four weeks for abdominal pain, distention, flatus, and dyspepsia severity. Measured against the placebo, subjects receiving the probiotic capsules achieved significant improvements in abdominal pain and total gastrointestinal symptom score, as well as a non-significanttrendtoward improvement for abdominal distention. No statistical benefits were reported for the Severity of Dyspepsia Assessment Scale ⁵¹.

Hyperlipidemia

Hyperlipidemia is a medical term for abnormally high levels of fats (lipids) in the blood. The two major types of lipids found in the blood are triglycerides and cholesterol. Bacillus coagulans may positively affect lipid levels in animals and humans. This is thought to be due to its ability to bind cholesterol in the gut, and possible inhibition of the cholesterol-producing enzyme HMG-CoA reductase. Administration of Bacillus coagulans to rabbits resulted in a 90-percent inhibition in the rise of serum cholesterol second-ary to feeding of high cholesterol diets ⁵². Bacillus coagulans supplementation (360 million CFUs/day) in humans decreased total serum cholesterol from an average of 330 mg/dL to 226 mg/dL in 17 subjects with type 2 hyperlipidemia over a three-month time interval ²⁶. LDL-cholesterol and LDL:HDL ratios were also significantly decreased, with a slight increase in HDL-cholesterol. No changes in serum triglyceride levels were observed ²⁶.

Viral conditions

The effect of Bacillus coagulans on the immune response after exposure to adenovirus and influenza A was investigated in 10 subjects (average age 44 years) for 30 days ²³. Subjects were given a daily dose of Bacillus coagulans with two billion CFUs per capsule and assessed at baseline and after 30 days, acting as their own control. Whole blood samples were assessed for cytokine levels after T-cell exposure to the two viruses. In the nine subjects that were evaluable, 250- and 1,709-percent average increases in the TNF-α response to adenovirus and influenza A viruses, respectively, were observed after 30 days of treatment ²³.

Aphthous stomatitis

Mathur et al ⁵³ reported Sporlac® (Bacillus coagulans) at a dose of two tablets daily (120 million CFUs) was efficacious in clearing outbreaks of aphthous stomatitis, with resolution occurring within 2-3 days. Sharma et al ⁵⁴ found that Bacillus coagulans given at 120 million CFUs daily resolved aphthous stomatitis in as little as 2-3 days.

Tooth decay

Tooth decay (dental caries) is damage to a tooth that can happen when decay-causing bacteria in your mouth make acids that attack the tooth’s surface, or enamel. This can lead to a small hole in a tooth, called a cavity. If tooth decay is not treated, it can cause pain, infection, and even tooth loss. Dental caries in children are caused in part by salivary mutans Streptococci and are a common problem both in modern and underdeveloped countries. A freeze-dried powdered preparation of Bacillus coagulans (CFUs not noted) mixed in 20 mL of water was given to 50 children for 14 days and they were instructed to swish and swallow the mixture ⁵⁵. Fifty additional children received a similar prepara-tion containing L. rhamnosus and Bifidobacterium species, while another group of 50 children were given an identically appearing placebo. Saliva samples were collected on day 1 and 14 and cultured for salivary mutans Streptococci. A statistically significant reduction in salivary mutans Streptococci counts was observed in both probiotic treatment groups after 14 days, suggesting Bacillus coagulans may be a cost-effective probiotic for preventing dental caries in children ⁵⁵.

Vaginitis

Vaginitis is an inflammation of the vagina that can result in discharge, itching and pain. The cause is usually a change in the normal balance of vaginal bacteria or an infection. Reduced estrogen levels after menopause and some skin disorders can also cause vaginitis. Vaginal administration of a commercial formula-tion of Bacillus coagulans tablets called Myconip® was given to 44 women with non-specific vaginitis twice daily for 14 days. Total CFUs per tablet was not specified. Subjects with Trichomonas or Candida vaginitis were excluded from the study. Complete relief of pruritis and discharge was reported by 91 percent of subjects ⁵⁶. These results were thought to be due to a beneficial change in vaginal acidity via lactic acid production by Bacillus coagulans. Postmenopausal subjects had a slower response to therapy but eventually had complete relief as well ⁵⁶.

Rheumatoid arthritis

Rheumatoid arthritis (RA) is an autoimmune disease that can cause joint pain and damage throughout your body. The joint damage that RA causes usually happens on both sides of the body. So, if a joint is affected in one of your arms or legs, the same joint in the other arm or leg will probably be affected, too. The anti-inflammatory and immune-modulating properties of Bacillus coagulans and other lactic acid-producing probiotics theoretically may have an impact on the symptoms of arthritis. In a random-ized, controlled trial, 44 adult men and women (average age 62) with rheumatoid arthritis for at least one year received either Bacillus coagulans with two billion CFUs or placebo daily for 60 days, in addition to their regular arthritis medications ¹⁹. Evaluations were conducted at baseline, 30, and 60 days for pain, disability, and global assessment by both patients and physicians. Subjects in the treatment group experienced statistically signifi-cant improvement in pain scale scores, patient pain assessment, and patient global and disability assessment when compared to placebo. Although physician assessment showed slight improvement in all categories, the results did not reach statistical significance. A reduction in C-reactive protein (CRP) was seen in the treatment group, but not in the placebo group. Subjects in the treatment group also demonstrated greater ability to walk two miles, reach, and participate in daily activities ¹⁹.

Bacillus coagulans dosage

Bacillus coagulans daily dosages reported in peer-reviewed research range from 100 x 10 ⁶ (100 million) to 5 x 10 ⁹ (5 billion) colony-forming units (CFUs). Beneficial effects were noted in earlier studies, even at dosages as low as 100 million CFUs daily. Currently, for Bacillus coagulans supplied in capsules, a typical dosage recommendation is 100 mg 2-3 times daily, with each 100 mg containing approximately 1.5 billion colony-forming units (CFUs).

Adults by mouth:

• For a long-term disorder of the large intestines that causes stomach pain (irritable bowel syndrome or IBS): Bacillus coagulans (Lactospore, Sabinsa Corporation) 2 billion colony forming units (CFUs) daily for 90 days. Bacillus coagulans (GanedenBC30, Ganeden Biotech Inc.) 300 million to 2 billion CFUs daily for 8 weeks. Also, a specific combination product (Colinox, DMG Italia SRL) containing Bacillus coagulans and simethicone has been used after each meal three times daily for 4 weeks.

Bacillus coagulans side effects

Toxicological safety assessments for Bacillus coagulans indicate no mutagenic, clastogenic, or genotoxic effects ¹². Results of an acute and 90-day subchronic oral toxicity study in rats yielded a No Adverse Effects Level (NOEL) greater than 1,000 mg/kg per day ⁵⁷. Bacillus coagulans at a concentration of 1.36 x 10 ¹¹ CFUs/g was used in the study, corresponding to 95.2 x 10 ¹¹ CFUs for a 70-kg human. Typical human dose range for Bacillus coagulans is 100 x 10 ⁶ (100 million) to 3 x 10 ⁹ (3 billion) CFUs daily, so this data represents a safety factor ranging from 3,173 to 95,200 times the recommended daily dose. In humans, adverse reactions following supplementation have not been reported in the peer-reviewed literature. For example, in the rheumatoid arthritis study, the authors mentioned that there were no treatment-related adverse events reported throughout the treatment period ¹⁹.

Bacillus coagulans is POSSIBLY SAFE when taken by mouth. Research shows that Bacillus coagulans in doses of 2 billion colony forming units (CFUs) daily can be safely used for up to 3 months. Lower doses of Bacillus coagulans up to 100 million CFUs daily can be safely used for up to 1 year.

Special precautions and warnings:

• Pregnancy and breast-feeding: There is not enough reliable information about the safety of taking Bacillus coagulans if you are pregnant or breast feeding. Stay on the safe side and avoid use.
• Children: Bacillus coagulans is POSSIBLY SAFE when taken by mouth in infants and children aged 6-18 years ⁵⁸. Some research has shown that Bacillus coagulans up to 100 million colony forming units (CFUs) daily can be safely used by infants for up to one year. Previous studies in pediatric patients with chronic gastrointestinal disorders showed that probiotics are well tolerated with no adverse effects ⁵⁹.

Bacillus coagulans interactions with medications

Be cautious with this combination.

• Antibiotic drugs: Antibiotics are used to reduce harmful bacteria in the body. Antibiotics can also reduce other bacteria in the body. Taking antibiotics along with Bacillus coagulans might reduce the potential benefits of Bacillus coagulans. To avoid this potential interaction, take Bacillus coagulans products at least 2 hours before or after antibiotics.
• Medications that decrease the immune system (immunosuppressants): Bacillus coagulans might increase the activity of the immune system. Taking Bacillus coagulans along with medications that decrease the immune system’s activity might decrease the effectiveness of these medications. Some medications that decrease the immune system’s activity include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), corticosteroids (glucocorticoids), and others.

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