Welcome : Welcome 1 PROBIOTICS: HEALTH BENEFITS, EFFICACY AND SAFETY : PROBIOTICS: HEALTH BENEFITS, EFFICACY AND SAFETY Amit Sharma
25-09-2010 2 PROBIOTICS : PROBIOTICS According to FAO/WHO Probiotics are the live microorganisms which when administered in adequate numbers confer a health benefit on the host…
(Banrjee and Verma 2010) 3 History of Probiotics : History of Probiotics Doderlein was the first who suggest beneficial association of vaginal bacteria, inhibiting the growth of pathogens..
E. Metchnikoff postulates the health benefits of Lactic acid bacteria associated with fermented milk products
Tissier in early 1900’s isolated Bifidobacterium from feces of a breast fed infant. 4 (Goktepe et al. 2006) History of Probiotics… : History of Probiotics… Nissle in 1917, isolated E. coli from feces of a soldier and used the strain in prevention of Shigellosis
In 1935, it was reasoned that human gut bacteria were more likely produce the desired effects in gut and Lactobacillus acidophillus were found very active when implanted in human gut (http://en.wikipedia.org/wiki/Probiotic)
Lilly and Stillwell in 1965, first introduced the term “Probiotics” which was later on redefined by Fuller (1989).
(Banrjee and Verma 2010) 5 Target Organ of Probiotics : Target Organ of Probiotics Intestinal micro flora
50 Bacterial Genera
1014 microbial cell
Functions of intestinal micro flora
Synthesis of nutrients like vitamins
Production of short chain fatty acids
Production of antimicrobial substances
Stimulation of immune system
Maintenance of gut barrier function Microbes used as Probiotics : Microbes used as Probiotics Two main groups of microbes are used with a safe history, these are..
1. Lactobacillus 2. Bifidobacterium 7 Microbes used as Probiotics : Microbes used as Probiotics Various other microorganisms used as Probiotics includes…
(Goktepe et al. 2006) 8 Slide 9: 9 Selection criteria for Probiotics : Selection criteria for Probiotics Few desirable traits that are considered important in strain selection are…
Tolerance to acid and bile.
Adherence to intestinal cells.
Competition for organic nutrients. 10 (Goktepe et al. 2006) Probiotics: Mechanism of Action : Probiotics: Mechanism of Action Competitive inhibition
Production of various substances (Enzymes, Short chain fatty acid, Bactericidal agents)
Ability to alter local pH and physiology.
(Goktepe et al. 2006) 11 Health Benefits of Probiotics : Health Benefits of Probiotics Antibiotic Associated Diarrhea
Diarrhea is most common side effect of antibiotic therapy.
Antibiotic may change the internal microflora
which results in diarrhea.
Probiotic agents used to control AAD includes
Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus.
http://en.wikipedia.org/wiki/Probiotic 12 Health Benefits cont.. : Health Benefits cont.. Rotavirus Diarrhea
This is a significant cause of mortality of infants in developing countries.
Approximately 80% of children with diarrhea are positive to rotavirus.
Lactobacillus GG found very effective in treating rotavirus diarrhea.
(Guo, M. 2009). 13 Health Benefits Cont… : Health Benefits Cont… Lactose Intolerance
Many peoples throughout the world suffer from the deficiency of ß- galactosidase enzyme.
Lactase strain of bacteria are added to pasteurized dairy product to increase digestibility of lactose present in dairy products.
(Goktepe et al. 2006) 14 Health Benefits Cont… : Health Benefits Cont… Pouchitis
This is a ileal reservior complication
occuring in surgery patients.
Investigators found Lactobacillus GG
strain is effective in treatment of pouchitis.
(Guo, M. 2009) 15 Health Benefits Cont… : Health Benefits Cont… Irritable Bowel Syndrome
It is characterized by chronic recurrent pain occurs primarily in childhood.
There is no specific treatment present for this disease.
Bifidobacterium infantis and Lactobacillus plantarum are found to reduce symptoms of irritable bowel syndrome.
(Goktepe et al. 2006 and Guo, M. 2009) 16 Health Benefits Cont… : Health Benefits Cont… Cholesterol Lowering
Animal studies demonstrated that Lactic Acid Bacteria are able to lower down the serum cholesterol level by breaking down bile in gut. 17 Slide 18: 17 Lactic acid bacilli Bile Acid deconjugation
Bile acid synthesis Increases
More cholesterol is used up
Decreases plasma cholesterol Helping to treat high cholesterol Health Benefits Cont… : Health Benefits Cont… Helicobacter pylori infection
H. pylori colonize stomach mucosa and is associated with gastritis, stomach carcinoma and gastric ulcer.
Certain lactic acid bacteria have inhibitory effect on this organism.
(Guo,M. 2009 and http://en.wikipedia.org/wiki/Probiotic) 19 Health Benefits Cont… : Health Benefits Cont… Stimulation of Immune System
Probiotics are able to enhance both innate and acquired immunity.
They will increase natural killer cells, immunoglobulin and phagocytes.
Two strains are developed particularly to enhance immune system that are..
HOWAROTM Bifido (B. lactis HN019)
HOWAROTM rhamnosus (L. rhamnosus HN001)
(Goktepe et al. 2006) 20 Health Benefits Cont… : Health Benefits Cont… Respiratory Tract Infections
Probiotic Yogurt drink having Lactobacillus rhamnosus GG, L. acidophilus 145 and Bifidobacterium was shown to reduce the occurrence of potentially pathogenic bacteria
in nose compared with a control yogurt. 21 Health Benefits Cont… : Health Benefits Cont… Throat Infections
Streptococcus salivarius in a product BLIS K12 throat guard is used to control strep throat infection in children caused by Streptococcus pyogenes.
(Goktepe et al. 2006) 22 Health Benefits Cont… : Health Benefits Cont… Colon Cancer
Many Lactic acid bacteria retard the growth of colon carcinogens by influencing metabolic, immunologic and protective functions in the colon.
Mechanism of action:
Alteration of metabolic activity of intestinal microflora.
Alteration of physiochemical conditions in the colon.
Quantitative and qualitative alteration in intestinal microflora.
Production of antitumorigenic or antimutagenic compounds
Enhancing the host immune response.
Effects on the physiology of the host. (Goktepe et al. 2006) Probiotic Products… : Probiotic Products… Yogurt
Fermented Juices 24 Probiotics in Food Safty… : Probiotics in Food Safty… Bacteria can produce some chemicals such as…
Bacteriocins (Nisin, Subtilin etc.)
These are used as Biopreservatives in food to retard spoilage and growth of pathogenic bacteria.
(Goktepe et al. 2006) 25 25 Efficacy of Probiotics : Efficacy of Probiotics Efficacy of probiotic strains depends on many factors including…
Transit to the target organ or surface.
Persistence within the target organ.
Adherence to the mucosal surface.
Reproduction with in the target organ. 26 Efficacy Of Probiotics Cont… : Efficacy Of Probiotics Cont… Interference in metabolic pathway of host.
Stimulation of immune system.
Safety within host organism.
Optimal dose range (107 – 108 CFU), frequency of administration and appropriate vehicle for delivery of probiotic strain. 27 Safety issues : Safety issues Main issues related to safety includes
Transfer of antibiotic resistance to other microbes present.
(Goktepe et al. 2006) 28 Guidelines Of FAO/WHO : Guidelines Of FAO/WHO In 2002 FAO/WHO laid down certain guidelines for the use of microbial strains as probiotics. These includes…
Established history of safe use in traditional products
Absence of significant risk with regards to transferable antibiotic resistance.
Absence of significant risk with regards to virulence factor.
Assessment of certain metabolic activities, such as D-lactate production, bile salt deconjugation.
Testing for toxin production of the strain used as probiotic.
Assessment of side effects during human studies.
Post Market surveillance of adverse incidents in consumers. Main regulatory bodies : Main regulatory bodies In Europe:
European Union Novel Food regulation (EUNF) 1997
European Food Safety Authority (EFSA) 2002
Qualified Presumption of Safety (QPS) by European Union Scientific Committee (EUSC) 2002
EU funded project “Biosafety Evaluation of Probiotic Lactic Acid Bacteria for Human Consumption” with objective to purpose recommendations towards evidence based safety assessment of probiotics for human use. Slide 31: Health Canada:
Natural health products regulations of the Canadian food and drugs act.
Food For Specific Health Uses (FOSHU):
The ministry of Health, Labor and Welfare, Japan introduced a system “Food For Specific Health Uses”
This was world’s First approval system of health claim labeling for food products.
This system was revised in 1997 to strengthen the regulation of quality control and simplify the documentation for FOSHU application. Indian Scenario : Indian Scenario The Indian probiotic market is worth INR 1.2 billion and growing annually at rate of about 40 percent.
It is currently regulated by extant food laws that regulate general food items includes…
Prevention of Food Adulteration Act,1952 and Rules of 1955 (PFA Act and Rules)
Essential Commodities Act, 1955
The Standards Weight and Measures Act,1976 and Rules of 1977 (SWMA Act and Rules)
The various authorities concerned includes:
The Ministry of Family and Health Welfare,
The Ministry of Food Processing Industries,
The Ministry of Consumers Affairs, Food and Public Distribution,
The Ministry of Agriculture. Indian Council of Medical Research : Indian Council of Medical Research Indian Council of Medical Research in January 2010 set guidelines for the use of microorganisms in food as probiotics. These includes… The nomenclature of the strain of the probiotic must conform to current internationally recognized names.
In vitro tests that include tests mimicking the host gut environment as well as animal studies for screening potential probiotic strains
In vivo tests in appropriate validated animal models
The Draft Guidelines suggest that certain tests shall be conducted even on Generally Recognized as Safe (termed as “GRAS”) probiotic strains,.
Probiotic foods should be manufactured using Good Manufacturing Practices (GMP) and the Codex General Principles of Food Hygiene and Guidelines for Application of Hazard Analysis and Critical Control Point (HACCP) should be followed. Labeling Requirements : Labeling Requirements ICMR also set guidelines for labeling of probiotic products
Genus, species and strain designation following the standard international nomenclature
The minimum viable numbers of each probiotic strain should be specified at the level at which efficacy is claimed and at the end of shelf- life.
Only evidence-based health claims should be stated on packet
The suggested serving size to deliver the minimum effective quantity of the probiotic related to the health claim.
Proper storage conditions to be mentioned. 34 CONCLUSION : CONCLUSION Probiotics as functional food gain much popularity in recent years. It was estimated that it contributes to 65- 70 % of total functional food market. The consumer of today is health conscious and demands food which are tasty as well as low in fat and calories, with additional health benefits. In present day society the leading health concerns are heart disease, cancer, high cholesterol and diabetes. Probiotics could be possible dietary treatment for these chronic disease. With this information available from scientific studies, use of probiotics for improving human health holds promise. 35 Thank you : Thank you 36 My name is Bacterium……
I’m not a Pathogen……