probiotics _by shyam sunder jayalwal

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]



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



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



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


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.



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



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



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



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


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.



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



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



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



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


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:



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



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.



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



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.


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




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.



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


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?


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?


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


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


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


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


REFERENCES:

1. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and

Nutritional Properties of Probiotics in Food Including Powder Milk with Live

Lactic Acid Bacteria (October 2001). "Health and Nutritional Properties of

Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria".

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

into the derivation and early uses of the word 'probiotic'". British Journal of

Nutrition 2003 (90): 845. Retrieved 19 November 2009.

3. Metchnikoff, E. 1907. Essais optimistes. Paris. The prolongation of life.

Optimistic studies. Translated and edited by P. Chalmers Mitchell. London:

Heinemann, 1907.

4. “General function” health claims under Article 13 at the Wayback Machine

(archived August 19, 2010)

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

Genomics to Probiotics. Caister Academic Press.

7. Wollowski I, Rechkemmer G, Pool-Zobel BL (February 2001). "Protective

role of probiotics and prebiotics in colon cancer". The American Journal of

Clinical Nutrition 73 (2 Suppl): 451S–455S.

8. Brady LJ, Gallaher DD, Busta FF (February 2000). "The role of probiotic

cultures in the prevention of colon cancer". The Journal of Nutrition 130 (2S

Suppl): 410S–414S. PMID 10721916

9. Kirjavainen PV, Salminen SJ, Isolauri E (February 2003). "Probiotic bacteria

in the management of atopic disease: underscoring the importance of

viability". J. Pediatr. Gastroenterol. Nutr. 36 (2): 223–7.

References


10. Hickson M, D'Souza AL, Muthu N et al (2007). "Use of probiotic

Lactobacillus preparation to prevent diarrhea associated with antibiotics:

randomised double blind placebo controlled trial". BMJ 335 (7610): 80.

11. Bravo, Javier et al (August 29, 2011). "Ingestion of Lactobacillus strain

regulates emotional behavior and central GABA receptor expression in a

mouse via the vagus nerve". Proceedings of the National Academy of

Sciences 108 (38). Retrieved 2 September 2011.

12. Sonomoto, K; Yokota, A (editor) (2011). Lactic Acid Bacteria and

Bifidobacteria: Current Progress in Advanced Research. Caister Academic

Press.

13. "Incorporating Probiotics into Food". pg. 60-67. Ross Crittenden, in

"Handbook of Probiotics and Prebiotics". Y. K. Lee and S. Salminen. 2nd

Edition. Ed. Wiley. (2009)

14. Besselink MG, van Santvoort HC, Buskens E et al (February 2008).

"Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised,

double-blind, placebo-controlled trial". Lancet 371 (9613).

15. Hun, Larysa MD, FAAP, L (2009). "Bacillus coagulans Significantly

Improved Abdominal Pain and Bloating in Patients with IBS". Postgraduate

Medicine 121 (2): 119–124. doi:10.3810/pgm.2009.03.1984. PMID 19332970

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

Microbiology (Blackwell Publishing) 103 (5): 1553–1561. Retrieved 7

November 2007.

References


19. Ji, Feng-Di; Ji, B.-P.; Li, B.; Han, B.-Z. (2007). "Note. Microbial Changes

During the Salting Process of Traditional Pickled Chinese Cabbage". Food

Science and Technology International (SAGE Publications) 13 (1): 11–16,

Retrieved 7 November 2007

20. "Health Benefits of Taking Probiotics." The Harvard Medical School Family

Health Guide Sept. 2005.

<http://www.health.harvard.edu/fhg/updates/update0905c.shtml>.

21. Bee, Peta (November 10, 2008). "Probiotics, Not so friendly after all". The

Times (London).

22. Islam MA, Yun CH, Choi YJ, Cho CS (2010). "Microencapsulation of live

probiotic bacteria" (PDF). Journal of Microbiology and Biotechnology 20

(1367–1377): 1367–1377.

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