Benefits of Probiotics in the Management of Gastrointestinal Disorders
Marketed products containing probiotics have become widely available during the last several
years. The popularity of probiotic-containing foods and dietary supplements has steadily
increased as more people seek ways to maintain their health. Probiotics are not new; they have
been available for a long time. The term probiotic, a term derived from the Greek language,
means for life and was first introduced in the 1960s. Today, however, the large number of
probiotic formulations added to various foods and supplements may be overwhelming to
consumers. Further, the role of probiotics in the prevention and treatment of medical conditions
may not be well understood among the health care community or the public.
There is a growing body of basic science and clinical trial data supporting the use of probiotics.
These agents are effective for a variety of medical indications, including gastrointestinal (GI)
disorders, such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), the
prevention of adverse GI effects from chemotherapy/radiation and antibiotic use, infant nutrition,
and respiratory conditions.1-5 Questions arise regarding differences among the available probiotic
formulations and how these agents should be properly prescribed, dosed, stored, and
administered. The pharmacist is well-positioned to provide consumers with information about
probiotics, so the most appropriate product may be selected according to the evidence-based
Awareness of Probiotics and Medical Foods
It has been within this century only that the concept of useful microbes has become accepted in
the health care industry and only within the past decade that probiotics has become a term
familiar to both health care providers and the public.6 Probiotics have been used in Europe for
decades, but have been widely introduced to the United States during the past 10 years. Other
than the general awareness that probiotics contain good bacteria and are added to food and
supplements, most people may not have useful knowledge of what probiotics are, what they do,
who should take them, and why.7,8
What Are Probiotics?
Probiotics are live microorganisms that provide a health benefit to the host when administered in
adequate amounts.9 Probiotics can be formulated into many different types of products, including
foods, drugs, and dietary supplements. Species of Lactobacillus and Bifidobacterium are most
commonly used as probiotics. However, the yeast Saccharomyces cerevisiae and some Escherichia coli and Bacillus bacteria species are also used as probiotics. Many probiotics
are lactic acid bacteria (LAB). LABs have been used to preserve food through fermentation for
thousands of years. LABs can serve as agents for food fermentation, while also having the
potential to impart health benefits as probiotics. LABs are defined as a functional classification
of nonpathogenic, nontoxigenic, gram-positive, fermentative bacteria that produce lactic acid
from carbohydrates.10 LABs include the Lactobacillus, Lactococcus, and Streptococcus
thermophilus species. Because Bifidobacterium is not associated with food fermentation, it is not
grouped with LABs although it is a probiotic.
Several related terms may be confused with probiotics. They are prebiotic, synbiotic, and
postbiotic. These terms are defined in Table 1.
|Table 1. Definitions
||Live microorganism when administered in adequate amounts confers a health benefit on the host.
||Nondigestible substance that provides a beneficial physiological effect for the host by selectively stimulating the favorable growth or activity of a limited number of indigenous bacteria. Common examples include: oligofructose, inulin, galacto-oligosaccharides, and lactulose.
||Product that contains both probiotics and prebiotics.
||A metabolic byproduct generated by a probiotic organism that influences the host’s biological functions.
Prebiotics stimulate the growth and/or activity of the body’s indigenous bacteria, or microbiota.
They consist primarily of nonstarch polysaccharides and oligosaccharides that are poorly
digested by human enzymes. Most prebiotics are used as food ingredients and some are found
naturally in foods, such as oligofructose, which is in wheat, onions, bananas, honey, garlic, and
leeks. Prebiotics can be isolated from chicory root as well. Chicory root is part of some
commercial probiotic combination formulations. The mechanisms of action for prebiotics
include increasing bifidobacteria in the colon, calcium absorption, fecal weight, and shortening
GI transit time.10
The Human Microbiota
Microbiota refers to the population of microscopic organisms that inhabit a particular organ or
portion of a person’s body.5 When an adequate amount of normal gut microbiota are present in
the GI tract, they aid digestion, reduce the colonization of harmful bacteria and help the GI
mucosal defenses, boosting the immune system. Intestinal microbiota benefit human health by
forming a mucosal barrier with the intestinal mucosa and mucus, creating an important defense system against infection.5 The population of microbiota increases in the GI tract, from the
stomach to the colon, as acid, bile, and pancreatic excretions decrease: The number of microbes
at the small intestine’s end is estimated at 106 to 107 colony forming units (CFUs); in the colon,
the number of microbes increases to between 1011 and 1012 CFUs/mL of intestinal contents.11 Recent genome analyses have confirmed the presence of over 1000 different bacterial species in
the microbiota, although 30 to 40 species account for the vast majority of the microbiota.5
The human intestinal microbiota and mucosa are part of a complex system that contributes to
immune system function, including oral tolerance and immunity. About two-thirds of the body’s
immune cells are estimated to be in the intestinal mucosa. Each individual has a unique bacterial
fingerprint, but a core group of about 57 bacteria are common to all.5 A person’s microbiota is
influenced by gender and age, as well as nutritional and health status. Intestinal microbes can be
affected by factors such as antibiotic use and immunosuppression. In most individuals, the
microbiota returns to normal without intervention and after a period of time.
How Probiotics Work
Probiotics are thought to benefit the GI tract by reestablishing the balance between good and bad bacteria.6 Probiotic effect varies by the bacterial strain, the dose ingested, host-related factors,
and the food vector.5 There are differences in how probiotic species withstand gastric acid and
colonize the intestinal tract.
Probiotics are thought to act through several mechanisms of action, including the following5:
- Probiotics interact with the intestinal epithelial cells to induce protective proteins and
regulate apoptosis (cell death); compete with pathogenic bacteria for both binding sites
on the intestinal wall and for nutrients; enact bacteriocidal actions, including lowering
intestinal pH by producing lactic, acetic, and/or propionic acids, as well as organic acids,
bacteriocins, and hydrogen peroxide; and modulate inflammatory signaling systems,
including enhancing phagocytic activity, producing immunoglobulin A, and stimulating
- Probiotics produce short chain fatty acid metabolites that play roles in fermentation,
which aid digestion.
- Probiotics synthesize vitamins, especially vitamin K and those in the B vitamin group.
- Probiotics increase mineral absorption.
- Probiotics detoxify carcinogens.
A recently published evidence-based review of probiotics and health noted the consumption of
probiotics and their influence on microbiota composition may “contribute significantly to human
health and well-being.”5 The researchers note that probiotic intake must be prolonged over time
to be effective. The dose of probiotics is measured in CFUs. To gain a high enough concentration
in the small and large intestines, probiotic concentrations should be ≥ 106 to 108 CFUs, although
scientific basis is somewhat weak. There is also no scientific evidence that 2 or more probiotic
strains ingested together will produce a synergistic effect in humans.5
A probiotic strain is identified by the genus, species, and an alphanumeric designation. In the
scientific community, there is an agreed nomenclature for microorganisms—for example, Lactobacillus casei DN-114 001 or Lactobacillus rhamnosus GG. The most commonly used
probiotic organisms are listed in Table 2.
|Table 2. Commonly Used Probiotic Strains10
|L acidophilus LA-5
||B animalis lactis Bb-12
|L acidophilus NCFM
||B animalis DN 173 010
||B bifidum CUL20
||Enterococcus faeciuma LAB SF68
|L casei DN-114 001
||B breve Yakult
||Escherichia coli Nissle 1917
|L casei CRL431
||B breve Bb99
|L casei F19
||B infantis 35624
||Saccharomyces boulardii lyo (yeast)
|L casei Lbc80r
||B lactis HN019
|L johnsonii La1
||B longum BB536
|L lactis L1A
|L plantarum 299V
|L reuteri ATTC55730
|L rhamnosus GG
|L rhamnosus LC705
Evidence of Probiotics Effectiveness and Safety
A growing body of preclinical and clinical data supports the use of probiotics for the prevention
and treatment of a large variety of medical conditions. Some conditions for which probiotic
studies have shown promising results include the following5:
- Preventing and reducing the severity of respiratory infections that are caused by an
increase in IgA-secreting cells in the bronchial mucosa
- Reducing the recurrence of yearly rhinitis in children
- Reducing the risk of early acute otitis media and reducing the use of antibiotics by infants
- Reducing fever, cough, rhinorrhea, and antibiotic use, as well as the occurance of missed
school days by children
- Reducing symptom severity and common cold duration in adults
- Reducing duration of common infectious diseases in the elderly
- Preventing and reducing the severity of antibiotic-associated diarrhea in children and
adults and reducing the risk of traveler’s diarrhea12,13
- Lowering the risk of necrotizing enterocolitis in premature and low birth weight infants14
- Preventing and treating acute infectious diarrhea, particularly pediatric Rotavirus, in
children and adults15
- Preventing diarrhea and multiple organ dysfunction syndrome in critically ill,
- Preventing diarrhea following chemotherapy or radiation therapy in cancer patients1,17
- Reducing the severity and duration of diarrhea among children with Rotavirus18
These studies support the safety of probiotics, even at very high doses. However, the majority of
clinical data have been in circulation for fewer than 5 years ; similarly, preclinical animal studies
have been conducted only within the last few decades. Recent articles and meta-analyses of
probiotics stress that there is a lack of clinical trials specifically designed to test probiotic
safety.19 The majority of information about safety has been obtained from individual case reports.
Published reviews note inconsistency in testing methods and a wide variation in doses, duration
of therapy, and outcomes measurements used. They call for additional research to determine the
best regimens by using specific probiotic strains for specific patient groups, over longer intervals,
with more comparative studies.6 In addition, the effects described in the studies can only be
attributed to the strain or strains tested and not to the species or the whole group of LABs or
other probiotics. Therefore, the safety of probiotics is related to their intended use, the dose and
treatment duration, and the potential patient vulnerability.
Probiotics are unique because they are alive when administered and they could have the potential
for infectivity or toxin production.28 Probiotics may theoretically be responsible for the following
4 types of side effects20:
- Systemic infections
- Deleterious metabolic activities, such as D-lactic acidosis in patients with short-bowel
- Excessive immune stimulation in susceptible individuals
- Gene transfer
There have been rare reports of systemic infections and probiotic consumption among patients
with underlying medical conditions or preexisting infections.9 Saccharomyces boulardii has been
associated with a few cases of sepsis, although contaminated IV lines may have been a factor.21
Because of these reports, care should be taken when administering probiotics to
immunocompromised patients or patients with chronic diseases, since there is limited
information regarding safety for use in these populations. A recently published review of one
meta-analysis and several randomized controlled trails (RCTs) involving probiotic use among
pregnant women in the third trimester conclude no increases in adverse fetal outcomes. These
data indicate probiotic use does not appear to pose any safety concerns for pregnant and lactating
women; however, there were no published studies addressing the use of Saccharomyces species.
Reviewers also note probiotics are unlikely to be transferred into breast milk.22 Probiotics are
being widely used in infant formulas. During an infant’s first few weeks of life, the education of
its immune system results from the exposure to breast milk and bacteria, both dietary and
potentially pathogenic. Supplementation with probiotics is generally considered safe; however,
studies have not yet compared the health benefits of breastfeeding with those of infant formula
plus probiotics products.5
Probiotics are generally well tolerated. Abdominal discomfort, flatulence, and bloating are the
most common side effects; they tend to occur early in use and are self-limiting.23
Probiotics for the Treatment of GI Disorders
GI disorders for which probiotics have been shown to be beneficial include irritable bowel
syndrome (IBS) and inflammatory bowel disease (IBD), which includes Crohn’s disease and
ulcerative colitis (UC).
IBS is a chronic GI condition with common symptoms, which include abdominal cramping or
pain and bloating and gassiness, as well as altered bowel habits (e.g., diarrhea and/or
constipation or both). IBS is divided into the following 3 subcategories: IBS with constipation
(IBS-C), where patients have hard stools more than 25% of the time and loose stools less than
25% of the time; IBS with diarrhea (IBS-D), in which patients have loose stools more than 25%
of the time and hard stools less than 25% of the time; and mixed/alternating (IBS-M), in which
patients have intermittent periods of diarrhea and constipation.
IBS is one of the most common conditions recorded in primary practice and the most frequent
reason for seeing a gastroenterologist. IBS has a population-wide prevalence of 14%,
predominantly among women24; its prevalence is approximately equal among the 3 types.
Patients with IBS were estimated to have made 3.6 million physician visits annually, resulting in
a financial expenditure of $1.35 billion direct and $205 million indirect costs in the United
States.25 While IBS was once generally believed to be caused by or exacerbated by stress,
organic and potentially postinfectious etiologies have recently come to light.26 Symptoms have
also been attributed to possible alterations in the intestinal microbiota and elevated levels of
A number of studies have described the clinical utility of probiotics for patients with IBS;
specifically, Kim et al observed reduced abdominal bloating and reduced flatulence3,28 in placebo-controlled trials involving a high-potency probiotic. In the first study, 25 patients with
IBS-D were randomly assigned to receive VSL#3 powder (450 billion lyophilized bacteria/day)
or placebo twice daily for 8 weeks. Pre- and posttreatment GI transit measurements were
performed in all patients. Results showed abdominal bloating was reduced (P = 0.046) in the
VSL#3 treatment group. VSL#3 had no effect on the following symptoms: abdominal pain, gas,
and urgency. All patients tolerated VSL#3 well. In the second RCT, 48 patients with Rome II
IBS were randomized to receive VSL# 3 twice daily (31 patients received 4 weeks and 17
patients 8 weeks of treatment). Treatment with VSL# 3 was associated with reduced flatulence
during the entire treatment period (P = 0.011).
Improvements in the symptoms of IBS were shown in a meta-analysis of 19 randomized trials;
although there is a continuing need for trials of a longer duration.28 The review found
methodological problems, including differences in probiotic strain, doses, duration of therapy,
and outcomes measured, in many of the trials. Almost all probiotic combinations contained both
bifidobacteria and lactobacilli. In single-organism studies, lactobacilli do not appear to confer a
health benefit to patients with IBS. When used in combination with bifidobacteria, lactobacilli
did not hinder the reduction of IBS symptoms. The bifidobacteria appear to be the active
ingredient in probiotic formulations and the systematic review shows formulations containing
bifidobacteria are more effective. This was also the conclusion of another meta-analysis
involving 16 RCTs, with specific reference to Bifidobacterium infantis 35624, which is thought to increase the ratio of certain interleukins.29 B infantis 35624 was shown to significantly
improve both global and individual IBS symptoms without an increase in adverse events.
IBD (UC, Pouchitis, Crohn’s Disease)
IBD is characterized by chronic inflammation in the intestinal tract; it includes 2 serious and
potentially life-threatening diseases, UC (which affects primarily the colon and rectum) and
Crohn’s disease (which can impact any portion of the GI tract). These conditions alternate
between periods of remission and exacerbations. During exacerbations, the patient may develop
fistulas and the risk of losing portions of the intestinal tract.30 Patients with IBD have an
increased risk of developing colon cancer. Symptoms include abdominal cramping, bloody
diarrhea, nausea, and fever. UC complications may include bleeding from deep ulcerations and
severe abdominal bloating. Potential complications from Crohn’s disease may include intestinal
blockage from swelling and scar tissue, accompanied by cramping pain, vomiting, and bloating,
as well as ulcers in the intestinal tract that may develop into fistulas. About one-third of patients
with Crohn’s disease experience infected fistulas. Eventually, nearly one-quarter of the patients
with UC and three-quarters of the patients with Crohn’s disease will require surgery.30
Annual health care costs attributable to IBD annually in the United States are more than $1.7
billion, making it one of the 5 most prevalent GI disease burdens. IBD accounts for more than
700,000 physician visits, 100,000 hospitalizations, and disability for 119,000 patients annually.30
Medications used to treat IBD consist of aminosalicylates (5-ASA), steroids, immune modifiers
(azathioprine, 6-mercaptopurine, and methotrexate), and antibiotics (metronidazole, ampicillin,
ciprofloxacin, others). In addition, inflixamab is used for the treatment of Crohn’s disease. Drug
therapies for IBD have significant side effects and do not result in remission for all patients, thus
probiotics could help to fill an important therapeutic need.31
UC: A number of RCTs have been published examining probiotic treatment during the induction
and remission of UC. As with many other probiotic trials, the following limitations may have
influenced results: the use of different probiotic strains (e.g., milk with Bifidobacteria/Lactobacillus and Escherichia coli Nissle 1917 versus other treatments and
VSL#3 versus other treatments); inadequate numbers of study participants (n = 18 to 327); and a
short duration of study (1 to 12 months). It is because of these study limitations a Cochrane
Database Systematic Review concluded that probiotics, when combined with other therapies, did
not improve remission rates; instead, they determined that treatment with probiotics produced a
reduction in disease activity for patients with mild-to-moderately severe UC.32 Another
systematic review concluded that the efficacy profile between probiotics and anti-inflammatory
medications is similar.33 More recent studies have established the following: a 77% remission
rate was achieved for a small number of participants with UC who were treated with VSL#3 and
who had not responded to conventional therapy34; a 56% remission rate was achieved in pediatric
individuals with mild-to-moderate UC (i.e., a combined remission/response rate of 61%)4; a 93%
remission rate was achieved for individuals treated with probiotics compared with a 36%
remission rate for those participants treated with placebo (both groups received concomitant drug
therapy) in an RCT involving children with UC35; and a significantly decreased incidence of UC
disease activity, compared with placebo, in a double-blind trial of adults with UC36; as well as a 68% success rate in achieving clinical remission in a small study using a 4-week course of S
These studies support the idea that specific probiotics may be effective for the short-term
treatment of patients with UC.
Pouchitis: For patients who have had reconstructive surgery following ileostomy secondary to
IBD, inflammation of the ileal pouch anastomosis or pouchitis is a common complication,
occurring in up to 50% of patients postsurgery. Decreased levels of lactobacilli and
bifidobacteria may contribute to the condition. A number of studies have demonstrated the safety
and efficacy of probiotics for the prevention and treatment of pouchitis.38-40 The combination
product, VSL#3, has provided the best evidence to date of effectiveness in preventing and
treating pouchitis. A 2010 meta-analysis concluded that VSL#3 is more effective than placebo
for preventing the onset and relapse of pouchitis.41
Crohn’s Disease: The literature is mixed with regard to the use of probiotics as induction
therapy or maintenance therapy for patients with Crohn’s disease. Methodological problems exist
regarding trials, particularly the small number of participants involved. Systematic reviews and
meta-analyses have concluded that probiotics were ineffective as maintenance therapy during
remission for patients with Crohn’s disease.42
Regulatory Status of Probiotics in the United States
In the United States, probiotics can be regulated as the following: foods, dietary supplements, or foods for special dietary uses (e.g., medicinal foods); drugs (either prescription or
nonprescription); medical devices; and cosmetics.43 The categorization of most products is
determined on the basis of the following 4 regulatory elements: route of administration,
formulation, safety, and the intended use. The probiotics in yogurts, desserts, or beverages are
considered food; while those formulated as dietary supplements are in dosage forms specified by
law, including powders, tablets, capsules, and drops. A medicinal food is intended for enteral use
in the “dietary management of a disease or condition for which distinctive nutritional
requirements have been established by medical evaluation” and is formulated to be administered
“under the supervision of a physician”. Most probiotics are marketed in the United States as food
products or dietary supplements; some, however, are marketed as medicinal foods, such as
VSL#3. Marketing probiotics as drugs would be very difficult and costly given they are natural
products and because of the rules governing drug development.42 This is why most
manufacturers choose to formulate and market probiotics as foods, medicinal foods, or dietary
Dietary supplements are governed by the Dietary Supplement Health and Education Act
(DSHEA) of 1994. A dietary supplement is defined as “a product (other than tobacco) that is
intended to supplement the diet that bears or contains one or more of the following dietary
ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance
for use by man to supplement the diet by increasing the total daily intake; or a concentrate,
metabolite, constituent, extract or combination of those ingredients.”
A dietary supplement may also be referred to as one of the following:
- A product that is intended for ingestion as a pill, capsule, tablet or liquid
- A product that is not represented for use as a conventional food or as the sole item of a
meal or diet
- A product that is labeled as a dietary supplement
- A product, such as a certified antibiotic or licensed biologic, may be marketed as a
dietary supplement or food before approval as a drug (e.g., psyllium)
The Food and Drug Administration (FDA) regulates dietary supplements under provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by DSHEA. Dietary supplements
are broadly presumed to be safe under DSHEA and the FDA does not have the authority to
require them to be approved for safety and efficacy before they enter the market. The FD&C Act was amended by the Dietary Supplement and Nonprescription Drug Consumer Protection Act of
2006. This Act requires manufacturers to abide by current Good Manufacturing Practices and to
notify the FDA about supplement-related serious adverse events, which may be defined as the
following: any health-related events that result in, for example, a death, a life-threatening
experience, an inpatient hospitalization, or a birth defect, or which require, based on reasonable
medical judgment, a medical or surgical intervention to prevent those serious outcomes.
DSHEA also prohibits manufacturers from making disease-related claims about their products.
They may only make nutrient-content claims and structure-function claims for dietary
supplements. This is the reason most probiotics are labeled very generally; for example, a
manufacturer may label its probiotic as one to “help naturally regulate your digestive system,”
which is a structure-function claim. Conversely, they would be prohibited from claiming the
product reduces UC remission unless they had tested and marketed the probiotic as a drug. This
is true even when clinical trials have shown demonstrated effectiveness for the treatment of
certain conditions. Because of these DSHEA requirements regarding claims, it can be difficult
for consumers to easily access any scientific evidence that might help them to choose a product.
The pharmacist, then, becomes a crucial resource for patients.
Probiotic Formulation, Administration, and Storage
A wide variety of probiotic supplements have been marketed and are currently available. Tables
3 and 4 list several probiotic food, medicinal food, and dietary supplement formulations.
Probiotic formulations may differ according to the bacterial strain(s) used and the amount of
CFUs present. To maximize effectiveness, the probiotic formulation must have a very high
bacterial count and must be able to reach the active site of the colon. It has been suggested that
concentrations of 106 CFUs/mL in the small intestine and 108 CFUs/gram in the colon are
needed, at minimum, for effectiveness; although these concentrations may vary based on
intended use.5 In addition, probiotics must be resistant to bile and stomach acids in sufficient
number. They must also be able to adhere to mucosa and colonize the GI tract for a substantial
period of time.
|Table 3. Select Food Probiotics
||Bifidobacterium animalis DN-173 010
|Stonyfield® Organic Yogurt
|YoBaby® Yogurt, YoBaby® Meals, YoToddler®
Lactobacillus rhamnosus GG
Lactobacillus rhamnosus GG
|Yo-Plus® With Probiotics
||Bifidobacterium lactis Bb-12
|Adapted from manufacturer Web sites.
|Table 4. Selected Probiotic Medicinal Foods and Supplements
||Bifidobacterium infantis 35624 (bifantis)
|Baby’s Only Essentials Probiotic®
||Bifidobacterium (longum, breve, infantis)
|Culturelle® Natural Health and Wellness
||Lactobacillus rhamnosus GG
|Culturelle® Probiotics for Kids
||Lactobacillus rhamnosus GG
|Culturelle® Digestive Health
||Lactobacillus rhamnosus GG
|Culturelle® Dairy Free
||Lactobacillus rhamnosus GG
|Digestive Advantage® Intensive Bowel Support®
||Bacillus coagulans GBI-30, 6086
|Enzymatic Therapy Pearls IC™
||Bifidobacterium (bifidum, lactis, longum, breve)
||Saccharomyces boulardii 250 mg
||Saccharomyces boulardii 250 mg
|Philips® Colon Health®
||Bacillus coagulans GBI-30, 6086
|Digestive Advantage® Daily Constipation Formula®
||Bacillus coagulans GBI-30, 6086
|Digestive Advantage® Gas Defense Formula®
||Bacillus coagulans GBI-30, 6086
Endo-cellulase, exo-cellulase, hemicellulase, invertase, alpha-galactosidase
|Digestive Advantage® Lactose Defense Formula®
||Bacillus coagulans GBI-30, 6086
Lactose 3000 FCC units
|Individual product Web sites and Lexi-Comp, Inc. (Lexi-Natural Products for Palm OS). Lexi-Comp, Inc.; September 30, 2011.5
Probiotics are most effective when dosed and administered correctly. Dosage is an important
consideration and varies widely from product to product: Please note, medicinal food probiotics
list dose recommendations according to the severity of the condition being treated. In addition,
because probiotics are live organisms, storage and shelf life are important. The number of CFUs
at the time of manufacture will decrease over time. A 50% to 90% loss of activity from the time
of manufacture until the expiration date, also called the “best by” date, may be expected. Many
manufacturers provide only the number of CFUs present when the product was manufacturered,
although labeling guidelines recommended otherwise.9
A July 2011 ConsumerLab.com report provides the results of their analysis of 13 probiotic
products for human consumption, which revealed that a number of products contained less CFUs
than the amount claimed on their labeling. The products analyzed were purchased from retail
stores, online venues, and through other commonly used purchasing means. ConsumerLab is an
independent provider of test results and information about health-related and nutritional products
and may be a worthwhile resource for the pharmacist to consider using.44
Probiotics should be kept refrigerated to help maintain potency. Some products will require
refrigeration or temperatures not in excess of room temperature, to maintain viability. For
example, VSL#3 must be shipped and stored under refrigeration. The powder formulation can be
mixed with cold foods, but cannot be mixed with carbonated beverages.
Since each probiotic formulation may have different strains, potency, storage, and expiration, it
is critical to review the product’s label when selecting an appropriate probiotic. The FAO/WHO
and WGO recommend each probiotic label contain the following information and adhere to the
- Genus, species, and strain designation; the strain designation should not mislead
consumers about the functionality of the strain. If the source is not provided on the label
it should be provided on the manufacturer’s Web site
- Minimum viable numbers of each probiotic strain at the end of the specified shelf life
- The suggested serving size must deliver the effective dose of probiotics related to the
- Number of servings/day
- Health claim(s)
- Expiration date and proper storage conditions
- Corporate contact details for consumer information (applicable phone numbers and Web
sites) The Web site should direct consumers and health care professionals to medical
literature that would allow them to assess the effectiveness of the product for a specific
In order to guide individuals while they choose probiotics, the pharmacist should be familiar
with existing data and the important clinical distinctions of these agents. A number of good Web
sites provide information about probiotics.
Select Probiotic Web Site Resources
American Gastroenterologic Association - www.gastro.org
ConsumerLab.com - www.ConsumerLab.com [subscription]
Consumer Reports - www.consumerreportshealth.org [subscription]
Council for Agricultural Science and Technology -
Food and Agriculture Organization of the United Nations (FAO)
International Scientific Association for Probiotics and Prebiotics -
National Institutes of Health. National Center for Complementary and Alternative
Medicine - http://nccam.nih.gov/health/probiotics/introduction.htm
usprobiotics.org: California Dairy Research Foundation and Dairy & Food Culture
Technologies - www.usprobiotics.org
When advising patients about the use of probiotics, it is critical to evaluate the patient’s specific
condition. Each product must be closely evaluated because probiotics are unique based upon
strain, formulation, and number of CFUs/dose. The choice to use one particular probiotic instead
of another should be based upon evidence gathered from clinical trials and human studies
demonstrating the benefit of using the formulation; the pharmacist may have to assist with
accessing and interpreting this information. In addition, the recommended dose should be based
upon the number of CFUs shown to be effective in clinical studies involving the specific product.
Effective use of a probiotic requires continual administration. Expiration dates and storage
conditions are important because these factors will affect the efficacy of the product; so, follow
packaging instructions when storing these products. Table 55 lists more detailed information
about the probiotic products used in a number of the clinical trials investigating treatments for
IBS and IBD.
Studies continue to be published in the medical literature, presenting solid evidence that
probiotics provide a clinical benefit for patients with GI disorders, including IBS and IBD.
Probiotics are uniquely formulated and regulated (including health claims) and this may make
selecting an appropriate product difficult for patients seeking advice about probiotic use. The
pharmacist should keep up-to-date regarding both the latest research and the effectiveness of
various probioticsm as a means to assist patients with selecting products and using them most
- Delia P, Sansotta G, Donato V, et al. Use of probiotics for prevention of radiation-induced
diarrhea. World J Gastroenterol. 2007;13(6):912-915.
- Gionchetti P, Lammers KM, Rizzello F, Campieri M. VSL#3: an analysis of basic and clinical
contributions in probiotic therapeutics. Gastroenterol Clin North Am. 2005;34(3):499–513, ix-x.
- Kim HJ, Vazquez Roque MI, Camilleri M, et al. A randomized controlled trial of a probiotic
combination VSL# 3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol
- Huynh HQ, deBruyn J, Guan L, et al. Probiotic preparation VSL#3 induces remission in
children with mild to moderate acute ulcerative colitis: a pilot study. Inflamm Bowel Dis.
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