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A
Project Report
on
PROBIOTICS
Project work submitted for partial fulfillment for the award of bachelor of pharmacy (B.Pharma.) degree.
Supervised By: Submitted By:Mr.Sandeep Kataria Shyam Sunder JayalwalAssit.Professor B.Pharma.Final year
MAHARSHI ARVIND INSTITUTE OF PHARMACY,
JAIPUR
2011-2012
Certificate
This is certify that Mr. Shyam Sunder Jayalwal student of B.Pharma. IV year
(Session 2011-2012) has carried out the project work entitled “Probiotics” as a
literature survey during final year for the partial fulfillment for the award of Bachelor
of Pharmacy degree, under direct supervision of me.
Mr. Sandeep Kataria Dr. RAJESH ASIJA
Assistant Professor Principal
MAIP, Jaipur MAIP, Jaipur
ACKNOWLEDGEMENT
My efforts this project reports were supported by many people, directly or indirectly,
and I would like to take this opportunity to thank them all them for their assistance. I
consider myself most lucky to work under the able guidance of Mr. Sandeep
Kataria. I take this opportunity to express my heartfelt gratitude to my reverend
guide, his discipline, principle, simplicity caring attitude and provision of fearless
work environment will be cherished in all walk of my life. I am very much grateful to
him for his invaluable guidance and everlasting encouragement throughout my
course.
I am immensely thankful Dr. RAJESH ASIJA(PRINCIPAL) Maharishi Arvind
Institute Of Pharmacy, Jaipur for providing me the necessary facilities and help in
carrying out my project work.
I owe my warmest and humble thanks to pharmacy faculty, Teaching staff of
Maharishi Arvind Institute Of Pharmacy, Jaipur for their timely help encouragement,
boosting my confidence in the progress of my academics.
I express my deepest and special thanks to my batch mates for their kind co-
operation, and encouragement through my graduation.
Last but not the least I thank “GOD” the almighty father, mother for their blessing
and courage to ladder the success.
Thankful I ever remain………………………..
SHYAM SUNDER JAYALWAL
(B.PHARMA, FINAL YEAR)
TABLE OF CONTENTS
S.NO. Chapter Page No.
1. INTRODUCTION 1-4
2. PRELIMINARY RESEARCH AND POTENTIAL EFFECTS
5-9
3. FACTORS AFFECTING VIABILITY IN FOODS 10-14
4. TYPES OF PROBIOTICS 15-21
5. HEALTH BENEFITS OF PROBIOTICS 22
6. WHAT FOODS CONTAIN PROBIOTICS? 23
7. HOW SHOULD PEOPLE TAKE PROBIOTICS? 24
8. THE SIDE EFFECTS AND RISKS OF PROBIOTICS 25-26
9. EFSA OPINIONS OF PROBIOTICS 27
10. REFERENCES 28-30
Chapter-1
INTRODUCTION
Chapter-1 Introduction
Maharishi Arvind Institute of Pharmacy, Jaipur 1
INTRODUCTION:
Probiotics are live microorganisms thought to be beneficial to the host organism.
According to the currently adopted definition by FAO/WHO, probiotics are: "Live
microorganisms which when administered in adequate amounts confer a health
benefit on the host".[1] Lactic acid bacteria (LAB) and bifidobacteria are the most
common types of microbes used as probiotics; but certain yeasts and bacilli may also
be used. Probiotics are commonly consumed as part of fermented foods with specially
added active live cultures; such as in yogurt, soy yogurt, or as dietary supplements.
Etymologically, the term appears to be a composite of the Latin preposition pro
("for") and the Greek adjective βιωτικός (biotic), the latter deriving from the noun
βίος (bios, "life").[2]
At the start of the 20th century, probiotics were thought to beneficially affect the host
by improving its intestinal microbial balance, thus inhibiting pathogens and toxin
producing bacteria. Today, specific health effects are being investigated and
documented including alleviation of chronic intestinal inflammatory diseases,
prevention and treatment of pathogen-induced diarrhea, urogenital infections, and
atopic diseases.[3]
To date, the European Food Safety Authority has rejected most claims that are made
about probiotic products, saying they are unproven. [4]
Chapter-1 Introduction
Maharishi Arvind Institute of Pharmacy, Jaipur 2
Histry:
Élie Metchnikoff
The original observation of the positive role played by certain bacteria was first
introduced by Russian scientist and Nobel laureate Élie Metchnikoff, who in the
beginning of the 20th century suggested that it would be possible to modify the gut
flora and to replace harmful microbes with useful microbes.[3] Metchnikoff, at that
time a professor at the Pasteur Institute in Paris, proposed the hypothesis that the
aging process results from the activity of putrefactive (proteolytic) microbes
producing toxic substances in the large bowel. Proteolytic bacteria such as clostridia,
which are part of the normal gut flora, produce toxic substances including phenols,
indols and ammonia from the digestion of proteins. According to Metchnikoff these
compounds were responsible for what he called "intestinal auto-intoxication", which
caused the physical changes associated with old age.
It was at that time known that milk fermented with lactic-acid bacteria inhibits the
growth of proteolytic bacteria because of the low pH produced by the fermentation of
lactose. Metchnikoff had also observed that certain rural populations in Europe, for
example in Bulgaria and the Russian steppes who lived largely on milk fermented by
lactic-acid bacteria were exceptionally long lived. Based on these facts, Metchnikoff
proposed that consumption of fermented milk would "seed" the intestine with
harmless lactic-acid bacteria and decrease the intestinal pH and that this would
suppress the growth of proteolytic bacteria. Metchnikoff himself introduced in his
Chapter-1 Introduction
Maharishi Arvind Institute of Pharmacy, Jaipur 3
diet sour milk fermented with the bacteria he called "Bulgarian Bacillus" and found
his health benefited. Friends in Paris soon followed his example and physicians began
prescribing the sour milk diet for their patients.
Bifidobacteria were first isolated from a breast-fed infant by Henry Tissier who also
worked at the Pasteur Institute. The isolated bacterium named Bacillus bifidus
communis was later renamed to the genus Bifidobacterium. Tissier found that
bifidobacteria are dominant in the gut flora of breast-fed babies and he observed
clinical benefits from treating diarrhea in infants with bifidobacteria. The claimed
effect was bifidobacterial displacement of proteolytic bacteria causing the disease.
During an outbreak of shigellosis in 1917, German professor Alfred Nissle isolated a
strain of Escherichia coli from the feces of a soldier who was not affected by the
disease. Methods of treating infectious diseases were needed at that time when
antibiotics were not yet available, and Nissle used the Escherichia coli Nissle 1917
strain in acute gastrointestinal infectious salmonellosis and shigellosis.
In 1920, Rettger demonstrated that Metchnikoff's "Bulgarian Bacillus", later called
Lactobacillus delbrueckii subsp. bulgaricus, could not live in the human intestine,
and the fermented food phenomenon petered out. Metchnikoff's theory was disputable
(at this stage), and people doubted his theory of longevity.
After Metchnikoff's death in 1916, the centre of activity moved to the United States.
It was reasoned that bacteria originating from the gut were more likely to produce the
desired effect in the gut, and in 1935 certain strains of Lactobacillus acidophilus were
found to be very active when implanted in the human digestive tract. Trials were
carried out using this organism, and encouraging results were obtained especially in
the relief of chronic constipation.
The term "probiotics" was first introduced in 1953 by Werner Kollath. Contrasting
antibiotics, probiotics were defined as microbially derived factors that stimulate the
growth of other microorganisms. In 1989, Roy Fuller suggested a definition of
probiotics that has been widely used: "A live microbial feed supplement which
Chapter-1 Introduction
Maharishi Arvind Institute of Pharmacy, Jaipur 4
beneficially affects the host animal by improving its intestinal microbial balance".
Fuller's definition emphasizes the requirement of viability for probiotics and
introduces the aspect of a beneficial effect on the host.
In the following decades, intestinal lactic acid bacterial species with alleged health
beneficial properties have been introduced as probiotics, including Lactobacillus
rhamnosus, Lactobacillus casei, and Lactobacillus johnsonii.[5]
Chapter-2
PRELIMINARYRESEARCH &
POTENTIALEFFECTS
Chapter-2 Preliminary Research And Potential Effects
Maharishi Arvind Institute of Pharmacy, Jaipur 5
PRELIMINARY RESEARCH AND POTENTIAL EFFECTS:
Experiments into the potential health effects of supplemental probiotics include the
molecular biology and genomics of Lactobacillus in immune function, cancer, and
antibiotic-associated diarrhea, travellers' diarrhea, pediatric diarrhea, inflammatory
bowel disease and irritable bowel syndrome. Testing of a probiotic usually applies to
a specific strain under study.
Diarrhea
Some probiotics have been shown in preliminary research to possibly treat various
forms of gastroenteritis. They might reduce both the duration of illness and the
frequency of stools. Fermented milk products (such as yogurt) also reduce the
duration of symptoms. [6]
Antibiotic-associated
Antibiotic-associated diarrhea (AAD) results from an imbalance in the colonic
microbiota caused by antibiotic therapy. Microbiota alteration changes carbohydrate
metabolism with decreased short-chain fatty acid absorption and an osmotic diarrhea
as a result. Another consequence of antibiotic therapy leading to diarrhea is
overgrowth of potentially pathogenic organisms such as Clostridium difficile.
Probiotic treatment might reduce the incidence and severity of AAD as indicated in
several meta-analyses. For example, treatment with probiotic formulations including
Lactobacillus rhamnosus may reduce the risk of antibiotic-associated diarrhea,
improve stool consistency during antibiotic therapy, and enhance the immune
response after vaccination. However, further documentation of these findings through
randomized, double blind, placebo-controlled trials are required to confirm specific
effects and attain regulatory approval, which currently does not exist.
Potential efficacy of probiotic AAD prevention is dependent on the probiotic strain(s)
used and on the dosage. Up to a 50% reduction of AAD occurrence has been found in
preliminary studies. No side-effects have been reported in any of these studies.
Chapter-2 Preliminary Research And Potential Effects
Maharishi Arvind Institute of Pharmacy, Jaipur 6
Caution should, however, be exercised when administering probiotic supplements to
immunocompromised individuals or patients who have a compromised intestinal
barrier.
Lactose intolerance
As lactic acid bacteria actively convert lactose into lactic acid, ingestion of certain
active strains may help lactose intolerant individuals tolerate more lactose than they
would otherwise have tolerated.[7]
Colon cancer
In laboratory investigations, some strains of LAB (Lactobacillus delbrueckii subsp.
bulgaricus) have demonstrated anti-mutagenic effects thought to be due to their
ability to bind with heterocyclic amines, which are carcinogenic substances formed in
cooked meat. Animal studies have demonstrated that some LAB have evidence for
acting against colon cancer in rodents, though human data are inconclusive. Some
human trials hypothesize that the strains tested may exert anti-carcinogenic effects by
decreasing the activity of an enzyme called β-glucuronidase[8] (which can generate
carcinogens in the digestive system). Lower rates of colon cancer among higher
consumers of fermented dairy products have been observed in one population study,
but confirmation of such an effect does not exist.
Cholesterol
Animal studies have demonstrated the efficacy some strains of LAB to be able to
lower serum cholesterol levels, presumably by breaking down bile in the gut, thus
inhibiting its reabsorption (which enters the blood as cholesterol).
A meta-analysis that included five double blind trials examining the short term (2-
8weeks) effects of a yogurt with probiotic strains on serum cholesterol levels found a
minor change of 8.5 mg/dL (0.22 mmol/L) (~4% decrease) in total cholesterol
Chapter-2 Preliminary Research And Potential Effects
Maharishi Arvind Institute of Pharmacy, Jaipur 7
concentration, and a decrease of 7.7 mg/dL (0.2 mmol/L) (~5% decrease) in serum
LDL concentration.
A slightly longer study evaluating the effect of a yogurt with probiotic strains on
twenty-nine subjects over six months found no statistically significant differences in
total serum cholesterol or LDL values. However, the study did note a significant
increase in serum HDL from, 50 mg/dL (1.28 mmol/L) to 62 mg/dL (1.6 mmol/L)
following treatment. This corresponds to a possible improvement of LDL/HDL ratio.
Studies specifically on hyper-lipidemic subjects are still needed.
Blood pressure
Although not a confirmed effect, some studies have indicated that consumption of
milk fermented with various strains of LAB may result in modest reductions in blood
pressure, an effect possibly related to the ACE inhibitor-like peptides produced
during fermentation.[7]
Immune function and infections
Some strains of LAB may affect pathogens by means of competitive inhibition (i.e.,
by competing for growth) and there is evidence to suggest that they may improve
immune function by increasing the number of IgA-producing plasma cells, increasing
or improving phagocytosis as well as increasing the proportion of T lymphocytes and
Natural Killer cells. Clinical trials have demonstrated that probiotics may decrease the
incidence of respiratory tract infections and dental caries in children. LAB products
might aid in the treatment of acute diarrhea, and possibly affect rotavirus infections in
children and travelers' diarrhea in adults, but no products are approved for such
indications.
A 2010 study suggested that probiotics, by introducing "good" bacteria into the gut,
may help maintain immune system activity, which in turn helps the body react more
Chapter-2 Preliminary Research And Potential Effects
Maharishi Arvind Institute of Pharmacy, Jaipur 8
quickly to new infections. Antibiotics seem to reduce immune system activity as a
result of killing off the normal gut bacteria. [7]
Helicobacter pylori
Some strains of LAB may affect Helicobacter pylori infections (which may cause
peptic ulcers) in adults when used in combination with standard medical treatments,
but there is no standard in medical practice or regulatory approval for such treatment.
Inflammation
Some strains of LAB may modulate inflammatory and hypersensitivity responses, an
observation thought to be at least in part due to the regulation of cytokine function.
Clinical studies suggest that they can prevent reoccurrences of inflammatory bowel
disease in adults, as well as improve milk allergies. They are not effective for treating
eczema, a persistent skin inflammation. How probiotics may influence the immune
system remains unclear, but a potential mechanism under research concerns the
response of T lymphocytes to pro-inflammatory stimuli.
Bacterial growth under stress
In a study done to see the effects of stress on intestinal flora, rats that were fed
probiotics had little occurrence of harmful bacteria latched onto their intestines
compared to rats that were fed sterile water.
Irritable bowel syndrome and colitis
In one study, a commercial strain of bifidobacterium infantis improved some
symptoms of irritable bowel syndrome in women. A separate small study showed that
a strain of Lactobacillus plantarum, may also be effective in reducing IBS symptoms.
A study focused on Bifidobacterium animalis showed a reduction in discomfort and
bloating in individuals with constipation-predominant IBS, as well as helping to
normalize stool frequency in said individuals. For maintenance of remission of
Chapter-2 Preliminary Research And Potential Effects
Maharishi Arvind Institute of Pharmacy, Jaipur 9
ulcerative colitis, Mutaflor (E.coli Nissle 1917) randomized clinical studies showed
equivalence of Mutaflor and mesalazine (5-ASAs). [9]
Other
A study in 2004 testing the immune system of students given either milk or Actimel
over a 6-week exam period (3 weeks of studying, 3 weeks of exams) tested 19
different biomarkers. Of these 19 biomarkers, only 2 were shown to be different
between the two groups, increased production of lymphocytes, and increased
production of CD56 cells. The tests were not blind and show that certain probiotic
strains may have no overall effect on the immune system or on its ability.
A 2007 study at University College Cork in Ireland showed that a diet including milk
fermented with Lactobacillus bacteria prevented Salmonella infection in pigs.[10]
A 2007 preliminary study at Imperial College London showed that a commercially
available probiotic drink containing Lactobacillus casei DN-114001 and yoghurt
bacteria might reduce the incidence of antibiotic-associated diarrhea and C difficile-
associated diarrhea.
The efficacy and safety of a daily dose of Lactobacillus acidophilus CL1285 in
affecting AAD was demonstrated in one preliminary study of hospitalized patients.
A 2011 study found that mice given Lactobacillus rhamnosus JB-1 showed lower
levels of stress and anxiety than controls. [11]
Current research is focusing on the molecular biology and genomics of Lactobacillus
strains and bifidobacteria. The application of modern whole genome approaches is
providing insights into bifidobacterial evolution, while also revealing genetic
functions that may explain their presence in the particular ecological environment of
the gastrointestinal tract.[12][13]
Chapter-3
FACTORSAFFECTING
VIABILITY INFOODS
Chapter-3 Factors Affecting Viability In Foods
Maharishi Arvind Institute of Pharmacy, Jaipur 10
FACTORS AFFECTING VIABILITY IN FOODS:
Some factors, both intrinsic and extrinsic, may influence the survival of probiotics in
food, and so have to be considerated in all stages of probiotic food manufacturing.
Physiological state of the added probiotic in the food
Physicochemical conditions of food processing
Physical conditions of product storage, like temperature
Chemical composition of the product, such as content of nutrients, oxygen or
pH
Interactions with other product components, that can be inhibitory or
protective.
Physiological state
The physiological state of bacteria when prepared and remaining in a product itself
are important factors for survival of the probiotics. Dryness in a food product keeps
the bacteria in a relatively quiescent state during storage, while a wet product
establishes potentially active metabolism. Temperature affects shelf life of the
bacteria, with low temperature providing conditions for possible long term survival.
Bacteria can respond to stressful environments by the induction of various stress
tolerance mechanisms. One of them is the induction of stress proteins by exposure of
the cells to sublethal stresses so they can condition probiotics to better tolerate
environmental stresses in food production, storage, and gastrointestinal transit.
Different probiotic strains have their own intrinsic tolerances to environmental
conditions, including how the culture is prepared, and some cross-protection can be
observed, providing protection against other stresses by the exposure to only one
stress. Stress responses can be explored to make probiotic strains more resilient and
likely to survive in food matrices, with significant industrial importance.
Chapter-3 Factors Affecting Viability In Foods
Maharishi Arvind Institute of Pharmacy, Jaipur 11
Temperature
The temperature at which probiotic organisms grow is an important factor in food
applications where fermentation is required, is also a critical factor influencing
probiotic survival during manufacture and storage. As it is told above, the lower the
temperature the more stable probiotic viability in the food product will be. During
processing, temperatures over 45–50°C will be detrimental to probiotic survival, this
means that the higher the temperature, the shorter the time period of exposure
required to severely decrease the numbers of viable bacteria, ranging from hours or
minutes at 45–55°C to seconds at higher temperatures. Therefore it is obvious that
probiotics should be added downstream of heating/cooking/pasteurization processes
in food manufacture to avoid the high temperatures. Elevated temperature also has a
detrimental effect on stability during the product process of shipping and storage.
Again, the cooler a product can be maintained, the better probiotic survival will be,
like in vegetative probiotic cells in liquid products, where refrigerated storage is
usually essential. If the product is dried, the bacteria will be in a quiescent state, so
acceptable probiotic viability can be maintained in dry products stored at ambient
temperatures for 12 months or more. Producing and maintaining low water activities
in the foods is the key to maintaining probiotic viability during nonrefrigerated
storage because there is a remarkable interaction between temperature and water
activity.
pH
Some bacteria like Lactobacilli and bifidobacteria can tolerate lower pH levels
because they produce organic acid and products from carbohydrate metabolism.
Indeed, numerous in vitro and in vivo studies have demonstrated that in gastric transit
where the cells are exposed to low pH values and with a time of exposure relatively
short, some probiotic organisms can survive. In fermented milks and yogurts with pH
values between 3.7 and 4.3. lactobacilli are able to grow and survive, while
Bifidobacteria tend to be less acid tolerant, with most species surviving poorly in
fermented products at pH levels below 4.6. B. animales subsp. lactis is most
Chapter-3 Factors Affecting Viability In Foods
Maharishi Arvind Institute of Pharmacy, Jaipur 12
commonly used in acidic foods because is more acid tolerant than human intestinal
species, and B. thermoacidophilum, is even more tolerant to low pH (and heat), but
has not yet been characterized thoroughly for probiotic traits and is not used
commercially.
Regarding to fruit juices (pH 3.5–4.5) commercially successful products have been
produced, such as Gefilus (Valio Ltd, Finland), which contains Lactobacillus
rhamnosus GG. The viability at low pH can be improved with carriers such as dietary
fibers. Survival of lactobacilli in low pHs has also been enhanced in the presence of
metabolizable sugars, that allow cell membrane proton pumps to operate and prevent
lowering of intracellular pH. This can improve survival during gastric transit, but may
not be applicable to improving probiotic survival over the time stages of shelf-
storage.
Water activity
For quiescent probiotic bacteria, water activity is a crucial determinant of survival in
food products during storage. The higher moisture levels and water activity, the lower
survival of probiotics. There is a substantial interaction between water activity and
temperature with respect to their impact on the survival of quiescent probiotics. As
the storage temperature is increased, the detrimental impact of moisture is magnified.
Here, the osmotic stresses appear to play a role, with the presence of smaller
molecules resulting in poorer bacterial survival, although the exact cell death
mechanisms have not been elucidated yet.
There may be technological limitations to reducing water activity to low levels for
improving survival. These include the energy costs of drying, adverse impacts on the
taste of foods and difficulties in wetting and dispersing powders. Moisture barrier
packaging may be applied to prevent the development of moisture from the
environment during storage. Maintaining probiotic viability in moderate water
activity foods (0.4–0.7) is a great challenge and solutions such as microencapsulation
Chapter-3 Factors Affecting Viability In Foods
Maharishi Arvind Institute of Pharmacy, Jaipur 13
or incorporation of probiotics into fat phases of products can provide improved
survival.
Oxygen
Both bifidobacteria and lactobacilli are considered strict anaerobes and oxygen can be
detrimental to its growth and survival. However, the degree of oxygen sensitivity
varies considerably between different species and strains, for example, lactobacilli,
which are mostly microaerophilic, are more tolerant of oxygen than bifidobacteria, to
the point where oxygen levels are not an important consideration in maintaining the
survival of lactobacilli. Most probiotic bifidobacteria do not grow well in the
presence of oxygen, although, many bifidobacteria have enzymatic mechanisms to
limit the oxygen toxicity.
For oxygen sensitive strains, some strategies can be used to prevent oxygen toxicity
in food products. Antioxidant ingredients have been shown to improve probiotic
survival, as well as the use of oxygen barrier or modified-atmosphere packaging.
Therefor, it is advisable to minimize processes that are highly aerating, particularly
when using bifidobacteria.
Toxicity of ingredients
Interactions between probiotics and other ingredients could happen and those
interactions can be protective, neutral, or detrimental to probiotic stability. Obviously,
the inclusion of antimicrobial preservatives can inhibit probiotic survival and elevated
levels of ingredients such as salt, organic acids, and nitrates can inhibit probiotics
during storage, while starter cultures can sometimes inhibit the growth of probiotics
during fermentation through the production of specific bacteriocins.
Growth factors, protective, and synergistic ingredients
Probiotic lactobacilli and, in particular, bifidobacteria are only weakly proteolytic and
grow relatively slowly or poorly in milk. The growth of bifidobacteria can be
Chapter-3 Factors Affecting Viability In Foods
Maharishi Arvind Institute of Pharmacy, Jaipur 14
improved by the presence of suitable companion cultures, which can aid in protein
hydrolysis and through the production of growth factors. Some growth substrates
such as carbon sources, nitrogen sources, and growth factors or antioxidants,
minerals, and vitamins can be added to improve growth. Finally, the food matrix itself
can be protective like in the cheese, where the anaerobic environment, high fat
content and buffering capacity of the matrix helps to protect the probiotic cells both in
the product and during intestinal transit.
Freeze–thawing
The damages made to cell membranes freezing probiotics is detrimental to survival,
and also can make the cells more vulnerable to environmental stresses. To prevent or
at least mitigate cell injury, protectants are usually added to cultures to be frozen or
dried. Once frozen, probiotics can survive well over long shelf lives in products such
as frozen yogurts and ice-cream. Using alternative methods of freezing, such as slow-
cooling rates or pre-freezing stress, can significantly improve cell survival. Repeated
freeze–thawing cycles are highly detrimental to cell survival and should be avoided.
Shear forces
Probiotic lactobacilli and bifidobacteria are Gram-positive bacteria with thick cell
walls that are able to tolerate the shear forces generated in most standard food
production processes such as high-speed blending or homogenization, that may result
in cell disruption and losses in viability.[14]
Chapter-4
TYPES OFPROBIOTICS
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 15
TYPES OF PROBIOTICS:
Probiotic products contain bacteria and/or yeasts that assist in restoring the balance in
our gut. Up until the 1960s, the gut microflora that they were able to identify were
clostridia, lactobacilli, enterococci, and Escherichia coli. Since then, innovative
techniques have discovered many more bacteria.
There are several different kinds of probiotics, and their health benefits are
determined by the job that they do in your gut. Probiotics must be identified by their
genus, species, and strain level. Here is a list of probiotics and their possible health
benefits.
1. Lactobacillus
There are more than 50 species of lactobacilli. They are naturally found in the
digestive, urinary, and genital systems. Foods that are fermented, like yogurt, and
dietary supplements also contain these bacteria. Lactobacillus has been used for
treating and preventing a wide variety of diseases and conditions.
Some of the lactobacilli found in foods and supplements are Lactobacillus
acidophilus, L. acidophilus DDS-1, Lactobacillus blugaricus, Lactobacillus
rhamnosus GG, Lactobacillus plantarium, Lactobacillus reuteri, Lactobacillus
salivarius, Lactobacillus casei, Lactobacillus johnsonii, and Lactobacillus gasseri.
More research is needed regarding probiotics and their potential health benefits
before any definitive claims can be made about their effects. However, studies have
shown some benefits linked to Lactobacillus and treating and/or preventing yeast
infections, urinary tract infection, irritable bowel syndrome, antibiotic-related
diarrhea, traveler's diarrhea, diarrhea resulting from Clostridium difficile, treating
lactose intolerance, skin disorders (fever blisters, eczema, acne, and canker sores),
and prevention of respiratory infections. More specifically, results from some of the
studies are as follows:
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 16
Lactobacillus GG was given to children 5 to 14 years of age with irritable
bowel syndrome over eight weeks' time. They were given 3 billion cells twice
per day. This reduced the frequency and severity of abdominal pain.
Lactobacillus GG was given to children taking antibiotics and there was a
decrease in reported diarrhea.
Lactobacillus casei, Lactobacillus bulgarius, and Streptococcus thermophilus
given twice daily during antibiotic treatment and for a week later decreased
the risk of diarrhea in hospitalized adults.
Lactobacillus GG-containing milk was given to children 1 to 6 years of age
who attended day care. They got fewer or less severe lung infections than
those who did not drink it.
Lactobacillus gasseri and Lactobacillus rhamnosus vaginal capsules
lengthened the time in between bacterial vaginosis infections.
Lactobacillus GG reduced the risk of traveler's diarrhea by 47% in a study
with 245 people who traveled to 14 worldwide geographic regions.
2. Bifidobacteria
There are approximately 30 species of bifidobacteria. The make up approximately
90% of the healthy bacteria in the colon. They appear in the intestinal tract within
days of birth, especially in breastfed infants.
Some of the bifidobacteria used as probiotics are Bifodbacterium bifidum,
Bifodbacterium lactis, Bifodbacterium longum, Bifodbacterium breve,
Bifodbacterium infantis, Bifodbacterium thermophilum, and Bifodbacterium
pseudolongum.
As with all probiotics, more research is needed to prove a definitive benefit, but
studies have shown that bifidobacteria can help with IBS, dental cavities, improved
blood lipids, and glucose tolerance.
Bifidobacterium infantis 35624 was given to 362 patients with irritable bowel
syndrome in a four-week study. They showed improvement in the symptoms
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 17
of abdominal pain, bloating, bowel dysfunction, incomplete evacuation,
straining, and the passage of gas.
Salivary levels of bifidobacteria are associated with dental cavities in adults
and children.
Bifidobacterium lactis Bb12 is reported to have beneficial effects on
metabolism, including lowered serum LDL-cholesterol in people with type 2
diabetes, increased HDL in adult women, and improved glucose tolerance
during pregnancy.
3. Saccharomyces boulardii
This is also known as S. boulardii and is the only yeast probiotic. Some studies have
shown that it is effective in preventing and treating diarrhea associated with the use of
antibiotics and traveler's diarrhea. It has also been reported to prevent the
reoccurrence of Clostridium difficile, to treat acne, and to reduce side effects of
treatment for Helicobacter pylori.
4. Streptococcus thermophilus
This produces large quantities of the enzyme lactase, making it effective, according to
some reports, in the prevention of lactose intolerance.
5. Enterococcus faecium
This is normally found in the intestinal tract of humans and animals.
a. E. faecium SF68
b. E . faecium M-74
6. Leuconostoc
This has been used extensively in food processing throughout human history, and
ingestion of foods containing live bacteria, dead bacteria, and metabolites of these
microorganisms has taken place for a long time.
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 18
Probiotic Research and Producer Information[15,16,17,18,19,]
Strain Brandname ProducerClaimed potential
effect in humans
Bacillus coagulans
GBI-30, 6086GanedenBC30
Ganeden
Biotech
May improve
abdominal pain and
bloating in IBS patients.
May increase immune
response to a viral
challenge.
Bifidobacterium
animalis subsp. lactis
BB-12
Probio-Tec
Bifidobacterium BB-
12
Chr. Hansen
Human studies have
shown that BB-12 alone
or in combination may
have an effect on the
gastrointestinal system.
Bifidobacterium
infantis 35624Align
Procter &
Gamble
In one preliminary
study, showed possible
improvement for
abdominal
pain/discomfort and
bowel movement
difficulty.
Lactobacillus
acidophilus NCFMDanisco
Shown in one study to
reduce the side effects
of antibiotic therapy.
Lactobacillus
paracasei St11 (or
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 19
NCC2461)
Lactobacillus
johnsonii La1 (=
Lactobacillus LC1,
Lactobacillus
johnsonii NCC533)
Nestlé
May reduce incidence
of H pylori-caused
gastritis and may reduce
inflammation
Lactobacillus
plantarum 299v
GoodBelly/ProViva/Pr
obiMageProbi
May improve symptoms
of IBS; however, more
research is required.
Lactobacillus reuteri
American Type
Culture
Collection|ATTC
55730 (Lactobacillus
reuteri SD2112)
BioGaia
Preliminary evidence
for diarrhea mitigation
in children, H. pylori
infection, possible
effect on gingivitis,
fever in children and
number of sick days in
adults.
Lactobacillus reuteri
Protectis (DSM 17938,
daughter strain of
ATCC 55730)
Saccharomyces
boulardiiDiarSafe and others
Wren
Laboratories
Limited evidence for
treatment of acute
diarrhea.
tested as mixture:
Lactobacillus
rhamnosus GR-1 &
Bion Flore
Intime/Jarrow Fem-Chr. Hansen
In one study, oral
ingestion resulted in
vaginal colonisation and
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 20
Lactobacillus reuteri
RC-14
Dophilus reduced vaginitis.
tested as mixture:
Lactobacillus
acidophilus NCFM &
Bifidobacterium
bifidum BB-12
Florajen3American
Lifeline, Inc
Preliminary evidence
for reduced C. difficile–
associated disease
(CDAD).
tested as mixture:
Lactobacillus
acidophilus CL1285 &
Lactobacillus casei
LBC80R
Bio-K+ CL1285
Bio-K+
Internationa
l
May affect digestive
health.
In vitro inhibition of
Listeria monocytogenes
and L. innocua,
Escherichia coli,
Staphylococcus aureus,
Enterococcus faecalis
and Enterococcus
faecium.
Reduction of symptoms
of lactose intolerance
and immune
stimulation.
Lactobacillus
plantarum HEAL 9 &
Lactobacillus
paracasei 8700:2
Bravo Friscus/
ProbiFriskProbi
Is under study for
common cold
infections.
Chapter-4 Types Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 21
Some additional forms of lactic acid bacteria include:
Lactobacillus bulgaricus
Streptococcus thermophilus
"Lactobacillus bifidus" - became new genus Bifidobacterium
Some fermented products containing similar lactic acid bacteria include:
Pickled vegetables
Fermented bean paste such as tempeh, miso and doenjang
Kefir
Buttermilk or Karnemelk
Kimchi
Pao cai
Sauerkraut
Soy sauce
MULTI-PROBIOTIC:
Preliminary research is evaluating the potential physiological effects of multiple
probiotic strains, as opposed to a single strain. As the human gut may contain several
hundred microbe species, one theory indicates that this diverse environment may
benefit from consuming multiple probiotic strains, an effect that remains scientifically
unconfirmed. [19]
Chapter-5
HEALTHBENEFITS OFPROBIOTICS
Chapter-5 Health Benefits Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 22
HEALTH BENEFITS OF PROBIOTICS:
Probiotics may seem new to the food and supplement industry, but they have been with us from our first breath. During a delivery through the birth canal, a newborn picks up bacteria from his/her mother. These good bacteria are not transmitted when a Cesarean section is performed and have been shown to be the reason why some infants born by Cesarean section have allergies, less than optimal immune systems, and lower levels of gut microflora.
Probiotics are believed to protect us in two ways. The first is the role that they play in our digestive tract. We know that our digestive tract needs a healthy balance betweenthe good and bad bacteria, so what gets in the way of this? It looks like our lifestyle is both the problem and the solution. Poor food choices, emotional stress, lack of sleep, antibiotic overuse, other drugs, and environmental influences can all shift the balance in favor of the bad bacteria.
When the digestive tract is healthy, it filters out and eliminates things that can damage it, such as harmful bacteria, toxins, chemicals, and other waste products. On the flip side, it takes in the things that our body needs (nutrients from food and water) and absorbs and helps deliver them to the cells where they are needed.
The idea is not to kill off all of the bad bacteria. Our body does have a need for the bad ones and the good ones. The problem is when the balance is shifted to have more bad than good. An imbalance has been associated with diarrhea, urinary tract infections, muscle pain, and fatigue.
The other way that probiotics help is the impact that they have on our immune system. Some believe that this role is the most important. Our immune system is our protection against germs. When it doesn't function properly, we can suffer from allergic reactions, autoimmune disorders (for example, ulcerative colitis, Crohn's disease, and rheumatoid arthritis), and infections (for example, infectious diarrhea, Helicobacter pylori, skin infections, and vaginal infections). By maintaining the correct balance from birth, the hope would be to prevent these ailments. Our immune system can benefit anytime that balanced is restored, so it's never too late.[20]
Chapter-6
WHAT FOODSCONTAIN
PROBIOTICS?
Chapter-6 What Foods Contain Probiotics?
Maharishi Arvind Institute of Pharmacy, Jaipur 23
WHAT FOODS CONTAIN PROBIOTICS?
Fermented dairy products have been advertised as containing "beneficial cultures."
These cultures are what would now be considered probiotics. Other foods currently
claiming to provide probiotics are cereal, juice, frozen yogurt, granola, candy bars,
and cookies. While they may contain probiotics, there is no guarantee that they have
them in the amount or in the form that is necessary to get the health benefits you are
looking for. Only the manufacturer of the product can tell you if there are any studies
to support their specific product.
Live probiotic cultures are available in fermented dairy products and probiotic
fortified foods. However, tablets, capsules, powders and sachets containing the
bacteria in freeze dried form are also available.
Few of the strains presented have been sufficiently developed in basic and clinical
research to warrant application for health claim status to a regulatory agency such as
the Food and Drug Administration or European Food Safety Authority, but so far no
claims have been approved.[15]
Chapter-7
HOW SHOULDPEOPLE TAKEPROBIOTICS?
Chapter-7 How Should People Take Probiotics?
Maharishi Arvind Institute of Pharmacy, Jaipur 24
HOW SHOULD PEOPLE TAKE PROBIOTICS?
The requirements for a microbe to be considered a probiotic are that the microbe must
be alive when administered, it must be documented to have a heath benefit, and it
must be administered at levels to confer a health benefit. These are live
microorganisms that will not provide the promised benefits if they don't stay alive.
The manufacturer and consumer must pay close attention to the conditions of storage
at which the particular microorganism will survive and the end of their shelf life. The
potency will tell you the number of viable bacteria per dose, and the purity has to do
with presence of contaminating or ineffective bacteria.
The other thing to remember is that these microorganisms are not all created equally.
In fact, the genus, strain, and species all need to be the same for the results that you
find in the study to be the results that you hope to achieve when taking it. For
example, with the strain Lactobacillus rhamnosus GG, the genus is Lactobacillus, the
species is rhamnosus and the strain is GG. If any one of those are different in your
supplement, you may not attain the same results.
With the growing popularity of probiotics, there is a huge variety of supplements
from which you can choose. The most important thing is to determine what type of
probiotic microorganism you need for your condition. Do not just take the
supplement that provides the most kinds of organisms. You need to do your research
and be sure that there are scientific studies to support what you take. New research is
emerging, so if you don't find what you need right, now keep looking. Your doctor
can help you decide if trying probiotics might be helpful for you and can advise you
regarding the amount and type of probiotics that may be appropriate in your case.[20]
Chapter-8
THE SIDEEFFECTS AND
RISKS OFPROBIOTICS
Chapter-8 The Side Effects And Risks Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 25
THE SIDE EFFECTS AND RISKS OF PROBIOTICS:
In some situations, such as where the person consuming probiotics is critically ill,
probiotics could be harmful. In a therapeutic clinical trial conducted by the Dutch
Pancreatitis Study Group, the consumption of a mixture of six probiotic bacteria
increased the death rate of patients with predicted severe acute pancreatitis.
In a clinical trial conducted at the University of Western Australia, aimed at showing
the effectiveness of probiotics in reducing childhood allergies, researchers gave 178
children either a probiotic or a placebo for the first six months of their life. Those
given the good bacteria were more likely to develop a sensitivity to allergens.
Some hospitals have reported treating lactobacillus septicaemia, which is a potentially
fatal disease caused by the consumption of probiotics by people with lowered
immune systems or who are already very ill. [21]
There is no published evidence that probiotic supplements are able to replace the
body's natural flora when these have been killed off; indeed bacterial levels in feces
disappear within days when supplementation ceases.
Probiotics taken orally can be destroyed by the acidic conditions of the stomach. A
number of micro-encapsulation techniques are being developed to address this
problem.
Recent studies indicate that probiotic products such as yogurts could be a cause for
obesity trends. However, this is contested as the link to obesity, and other health
related issues with yogurt may link to its dairy and calorie attributes.
Some experts are skeptical on the efficacy of many strains and believe not all subjects
will benefit from the use of probiotics.
Chapter-8 The Side Effects And Risks Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 26
Supplements are not monitored in the U.S. the way that food or medication is. They
fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This
requires that the dietary supplement or dietary ingredient manufacturer be responsible
for ensuring that a dietary supplement or ingredient is safe before it is marketed. The
only time that the U.S. Food and Drug Administration (FDA) may get involved is if
action is needed to be taken against a manufacturer after the supplement is marketed
and then found to be unsafe. This means that as much as we may know about
probiotics, we can't be certain of the safety or content of the supplements available to
us.
There is one Voluntary Certification Program by which a supplement manufacturer
can choose to be evaluated. ConsumerLab.com (CL) is the leading provider of
independent test results and information to help consumers and health care
professionals identify the best quality health and nutrition products. Products that
have passed their testing for identity, strength, purity, and disintegration can print the
CL Seal of Approval on their product. This is one step toward being confident that
you are getting the amount and type of probiotic promised by the manufacturer. [22]
Chapter-9
EFSA OPINIONSOF PROBIOTICS
Chapter-9 Efsa Opinions Of Probiotics
Maharishi Arvind Institute of Pharmacy, Jaipur 27
EFSA OPINIONS OF PROBIOTICS:
The European Food Safety Authority has so far rejected 260 claims on probiotics in
Europe due to insufficient research and thus no conclusive proof. This includes:
Lactobacillus paracasei LMG P 22043 does not decrease potentially
pathogenic gastro-intestinal microorganisms or reduce gastro-intestinal
discomfort.
Lactobacillus johnsonii BFE 6128 . Immunity and skin claims all too general
for consideration under the NHCR.
Lactobacillus fermentum ME-3 not shown to decrease potentially pathogenic
gastro-intestinal microorganisms.
Lactobacillus plantarum BFE 1685. Immunity claim deemed too general for
NHCR.
Bifidobacterium longum BB536 does not improve bowel regularity; does not
resist cedar pollen allergens; does not decrease pathogens.
Bifidobacterium animalis ssp. lactis Bb-12 does not help maintain normal
LDL-blood cholesterol; does not decrease pathogens or boost immunity.
Lactobacillus plantarum 299v does not reduce flatulence and bloating or
protect DNA, proteins and lipids from oxidative damage.
Lactobacillus rhamnosus LB21 NCIMB 40564 does not help maintain
individual intestinal microbiota in subjects receiving antibiotic treatment.[5]
Chapter-10
REFERENCES
References
Maharishi Arvind Institute of Pharmacy, Jaipur 28
REFERENCES:
1. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and
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Lactic Acid Bacteria (October 2001). "Health and Nutritional Properties of
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Food and Agriculture Organization of the United Nations, World Health
Organization. Retrieved 2009-11-04.
2. Hamilton-Miller, Professor J. M. T.; G. R. Gibson, W. Bruck. "Some insights
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5. Vaughan RB (July 1965). "The romantic rationalist: A study of Elie
Metchnikoff". Medical History 9: 201–15.
6. Ljungh A, Wadstrom T, ed. (2009). Lactobacillus Molecular Biology: From
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10. Hickson M, D'Souza AL, Muthu N et al (2007). "Use of probiotic
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mouse via the vagus nerve". Proceedings of the National Academy of
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12. Sonomoto, K; Yokota, A (editor) (2011). Lactic Acid Bacteria and
Bifidobacteria: Current Progress in Advanced Research. Caister Academic
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14. Besselink MG, van Santvoort HC, Buskens E et al (February 2008).
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15. Hun, Larysa MD, FAAP, L (2009). "Bacillus coagulans Significantly
Improved Abdominal Pain and Bloating in Patients with IBS". Postgraduate
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16. http://www.chr-
hansen.com/fileadmin/user_upload/_temp_/Selected_summaries_BB-12.pdf
17. Robinson, R.K., ed. (2007). "Sellars, R.L.". Acidophilus Products
(Therapeutic Properties of Fermented Milks). Chapman & Hall, London.
pp. 81–116.
18. Seseña, S; Palop, ML; M.Ll. Palop (2007). "An ecological study of lactic acid
bacteria from Almagro eggplant fermentation brines". Journal of Applied
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