Alternative Medicine Review 2012 (Mar); 17 (1): 76–81 ~ FULL TEXT
Julie S. Jurenka, MT (ASCP)
Thorne Research, Inc.,
Dover, ID 83825, USA.
Probiotics are defined by the World Health
Organization as “live microorganisms which, when
administered in adequate amounts, confer a health
benefit on the host.”  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.  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
Bacillus coagulans is a gram-positive, spore-forming,
microaerophilic, lactic-acid producing bacillus.
It was originally isolated and described in 1932 by
Horowitz and Wlassowa and named Lactobacillus
sporogenes (L. sporogenes).  In 1957, the organism
was reclassified in Bergey’s Manual of Determinative
Bacteriology based on its biochemical properties,
and the current correct nomenclature is Bacillus
coagulans (B. coagulans).  However, the organism is
still sometimes referred to as L. sporogenes; for the
purposes of this monograph, the correct nomenclature
– B. coagulans – will be used. B. coagulans is
unique among probiotics in that it possesses a
protective, spore-like protein coating, which allows
it to survive stomach acid, reach the small intestine,
germinate, and multiply. The organism requires a
complex mixture of organic substrates for growth,
including fermentable carbohydrates and peptides. 
Subsequent to oral administration, B. 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.
Upon arrival in the duodenum, the spores germinate
and multiply rapidly. Estimates suggest the
average duration of time between oral dosing and
germination is 4-6 hours,  with approximately 85
percent of the starting material reaching the
intestinal tract. After germination, B. 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).  B. coagulans is
considered a transient colonizing probiotic,
indicating it takes up only temporary residence in
the human intestines.  Spores of B. coagulans are
excreted slowly via the feces for approximately
seven days after discontinuation of
Mechanisms of Action
Despite the transient nature of this organism in
the digestive tract, it is thought to produce a shift
in the intestinal environment in support of a
complex gastrointestinal flora. [6-8] This is presumed
to be a result of improving gastrointestinal ecology
by replenishing the quantity of desirable obligate
microorganisms and antagonizing pathogenic
microbes. [3, 6]
B. coagulans has also been shown in vitro to
produce bacteriocins,  bacteriocin-like substances, 
and short-chain fatty acids that nourish the colonic
mucosa.  Bacteriocins are peptides produced by
some strains of bacteria that inhibit the growth of other bacteria. Coagulin, a bacteriocin-like substance,  and lactosporin, a unique antimicrobial
protein with a lipid moiety,  have been isolated
from B. coagulans and demonstrate significant
antibacterial activity. [9, 11]
In vitro bioassays have also shown components
of the cell wall and supernatant of certain strains
of B. coagulans influence gut inflammation via
cytokine modulation, inhibition of reactive oxygen
species, and enhanced phagocytosis.  Research in
humans has also shown B. coagulans GBI-30-6086
increased tumor necrosis factor-alpha (TNF-α)
response to adenovirus by 250 percent over
baseline after 30 days of treatment. A 1,709-percent
increase in the TNF-α response to influenza A
was also noted, but no effect was observed for
other strains of influenza.  Antifungal activity by
B. coagulans has also been demonstrated in vitro
against Fusarium species, although the mechanism
behind this has not been determined. 
B. coagulans possesses significant b-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. [3, 15] B. 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). 
An optimal balance between indigenous beneficial
bacteria and potentially pathogenic bacteria in
the gut is essential for efficient digestion and
nutrient absorption. Imbalances in the gastrointestinal
milieu can occur during antibiotic therapy,
immune suppression, allergy insult, and stress.
Probiotic administration has been shown to be an
effective therapy for modulating a variety of
gastrointestinal disorders (Table 1).
Bacillus coagulans GI Studies
In laboratory animals with bacterial dysbiosis, B.
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. [6, 7] It has also been reported that B. 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.  It
should be noted that English full-text versions of
these studies [7, 8] were not available, so detailed
information is lacking.
In a 2007 systematic review of the literature
including 10 randomized trials and 1,986 children,
B. 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 B. 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 B.
coagulans-fructo-oligosaccharide preparation for 10
days. At the end of the treatment period, only 29
percent of children in the B. 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). 
Irritable Bowel Syndrome
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 B.
coagulans have been studied as a therapy for IBS in
two randomized, double-blind clinical trials.
In one eight-week study, 52 men and women
(ages 30-67) with diarrhea-predominant IBS
(IBS-D) were randomized to receive one capsule
daily of B. coagulans with two billion colony
forming units (CFUs) (n=26) or identically appearing
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 B. coagulans group when compared to
placebo (p=0.042); differences between treatment
and placebo groups for other parameters did not
reach statistical significance. 
In the second study, 44 subjects with IBS-D (82
percent women; average age 48 years) were randomized to either the B. coagulans (n=22) or
placebo (n=22) group. Those in the treatment
group received one capsule daily of B. coagulans
containing 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 B. 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 B.
coagulans may be an effective therapy for decreasing
bowel movement frequency, abdominal pain,
and bloating in patients with IBS. 
Neonatal and Infant Diarrhea
Research conducted in India has shown B.
coagulans is effective in decreasing frequency and
duration of neonatal diarrhea caused by acute
rotavirus infection. Administration of 100 million
CFUs of B. 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
B. coagulans administration had no impact on
necrotizing enterocolitis or rate of death in very
low birth weight neonates  or in older infants
(6-24 months) with diarrhea and dehydration. 
A randomized, double-blind, placebo-controlled
trial was conducted to evaluate the effects of B.
coagulans on post-prandial gas-related intestinal
symptoms. Sixty-one adults (average age 36.5
years) were randomized to receive two billion CFUs
B. 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-significant trend toward improvement for
abdominal distention. No statistical benefits were
reported for the Severity of Dyspepsia Assessment
B. 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 B.
coagulans to rabbits resulted in a 90-percent
inhibition in the rise of serum cholesterol secondary
to feeding of high cholesterol diets.  B. 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 II hyperlipidemia over a three-month
time interval. 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. 
The effect of B. coagulans on the immune
response after exposure to adenovirus and influenza
A was investigated in 10 subjects (average age
44 years) for 30 days. Subjects were given a daily
dose of B. 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. 
Mathur et al reported SporlacR (B. 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 found that B. coagulans given
at 120 million CFUs daily resolved aphthous
stomatitis in as little as 2-3 days. 
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
B. 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.
Fifty additional children received a similar preparation
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 (p<0.001) in
salivary mutans Streptococci counts was observed
in both probiotic treatment groups after 14 days,
suggesting B. coagulans may be a cost-effective
probiotic for preventing dental caries in children. 
Vaginal administration of a commercial formulation
of B. 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. These results
were thought to be due to a beneficial change in
vaginal acidity via lactic acid production by B.
coagulans. Postmenopausal subjects had a slower
response to therapy but eventually had complete
relief as well. 
The anti-inflammatory and immune-modulating
properties of B. coagulans and other lactic acid-producing
probiotics theoretically may have an
impact on the symptoms of arthritis. In a randomized,
controlled trial, 44 adult men and women
(average age 62) with rheumatoid arthritis for at
least one year received either B. coagulans with two
billion CFUs or placebo daily for 60 days, in
addition to their regular arthritis medications.
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 significant
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 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. 
Toxicity and Side Effects
Toxicological safety assessments for B. coagulans
indicate no mutagenic, clastogenic, or genotoxic
effects. 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.  B. coagulans at a concentration of 1.36 x 1011
CFUs/g was used in the study, corresponding to
95.2 x 1011 CFUs for a 70-kg human. Typical
human dose range for B. coagulans is 100 x 106 (100
million) to 3 x 109 (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
B. coagulans daily dosages reported in peer-reviewed
research range from 100 million to 5
billion CFUs. Beneficial effects were noted in earlier
studies, even at dosages as low as 100 million CFUs
daily. Currently, for B. 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. It
should be noted that several of the human studies
cited in this monograph were conducted using a
patented/proprietary strain of B. coagulans
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