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What is Prebiotic?
Nondigestible substances that provide a beneficial physiological effect for the host by selectively stimulating the favorable growth or activity of a limited number of indigenous beneficial bacteria Commonly known prebiotics are Oligofructose Inulin Galactooligosaccharides Lactulose, Breast milk oligosaccharides (3-6 gm/dl). The prebiotic oligofructose is found naturally in many foods eg wheat, onions, bananas, honey, garlic and chicory roots
What is a Probiotic
An oral supplement or a food product that contains a sufficient number of viable microorganisms which, when administered orally, alter the micro flora of the host and confer a health benefit on the host Most common forms of probiotics are Dairy products , eg yoghurt Probiotic fortified foods Capsules/sachets containing freeze dried bacteria
The most studied probiotic bacteria to date are Lactobacillus rhamnosus GG(LGG), Bifidobacterium lactis, Streptococcus thermophilus
Symbiotic
A combination of prebiotic & probiotic
Functional food
Any modified food , that provides a health benefit beyond that ascribed to any of the specific nutrients it contains Eg : Live culture yoghurt, breast milk
Infants gut is sterile but bacterial colonization occurs rapidly on starting enteral feeds
The ingested human milk containing bacterial components derived from mother are thought to influence the infants developing immune system (bacterial imprinting)
Beyond infancy, composition of fecal flora is less variable & not dependent on diet Human intestine contains more than100,000 billion bacteria Belong to > 100 different species Mainly in the colon Different people have different organisms Exhibhit a symbiotic relationship
contd
Intestine is the body's most important immune function related organ Approximately 60% of body's immune cells are present in intestinal mucosa and is called gut associated lymphoid tissue (GALT) Maturation and development of GALT depends on the development & composition of indigenous micro flora & vice versa This immune system controls immune response against dietary proteins & pathogenic microorganisms Interference with or dysregulation of this early development is thought to cause chronic diseases like atopy & autoimmune diseases
Activate local macrophages to increase antigen presentation to B lymphocytes and increase secretary immunoglobulin A
Digest food and compete for nutrients with pathogens Alter local pH to create unfavorable local environment for pathogens
Produce bactericidal substances like lactic & butyric acids & bacteriocins to inhibit pathogens
Scavenge super oxide radicals Stimulate epithelial mucin production Enhance mucosal barrier function Compete for adhesion with pathogens Modify pathogen derived toxins
Sources of energy for the micro flora Resistant to digestive enzymes of the gut but fermentable by colonic micro flora and bifidogenic bacteria Production of SCFA Increase calcium absorption Increase fecal weight Shorten GI transit time Possibly lowers blood lipid levels Bacteriostatic activity by blocking receptors on T cells open for interaction with pathogens Enhance host immunity(IgA production, Cytokine modulation etc)
Safety concerns
The committee on Nutrition of the European Society of Pediatric Gastroenterology, Hepatology & Nutrition states that more studies are required to establish safety & efficacy. To date these products seem to be safe for healthy infants & children
Serious infections including sepsis & meningitis, endocarditis has been reported in neonates, infants, children & adults. Patients at risk are
- Immunocompromised - Preterm neonates - Children with indwelling catheters/medical devices
Safety concerns
Other possible adverse effects are Transfer of antibiotic resistance Lactic acidosis due to D lactate production as a metabolic by product Contamination Flatulence, bloating abdominal pain
Addition of probiotics to infant formula has not been demonstrated to be harmful in healthy term infant, but lacks evidence demonstrating clinical efficacy to recommend their routine use Addition of prebiotics is not unreasonable, but lacks evidence demonstrating clinical efficacy. Cost benefit studies are also necessary to support
Clinical applications
Decreases the number of diarrhea stools and duration of acute infectious diarrhea of viral etiology by 1 day, when started early in course of the disease. Prevents antibiotic associated diarrhea May be of some benefit as an adjuvant to eradicate H.pylori, but more studies are required
Treatment of ulcerative colitis. Probiotic E.Coli Nissle may be equivalent to mesalazine in maintaining remission. May reduce symptoms of irritable bowel syndrome Reduce symptoms of lactose intolerance May reduces risk of NEC in preterm>1kg Despite encouraging results of some studies, there is insufficient evidence to support routine use of probiotics in prevention or treatment on atopy Decreased risk of colorectal cancer in animal model
Product
L rhamnosus L reuteri L acidophilis + B infantis S boulardii
Daily Dose
1010 to 1011 cfu BD 1010 to 1011 cfu BD 109 cfu each TDS
200 mg TDS
Product
L rhamnosus L acidophilis + B infantis S boulardii
Daily Dose
1010 cfu OD/BD 107 + 106 cfu/gram 250 mg BD
109 cfu BD
1010 cfu BD
10x1010 cfu OD
E coli (Nissle 5X1010 bacilli BD 1917) VSL# 3 mixture 4.5X1011 cfu BD (S thermophilus, Lactobacillus, Bifidobacterium)
Product
Daily Dose
B infantis, S 0.35 X109 cfu each thermophilus, B OD bifidum L acidophilus + 109 cfu BD B infantis
Constipation Lactulose oligofructose Hepatic Lactulose Encephalop athy Lactose Yoghurt, intolerance L bulgaricus+ S thermophilus
Pasteurized Yoghurt
Available evidence does not support routine use of probiotics to prevent infectious diarrhea. Probiotics are not recommended for treatment of antibiotic associated diarrhea in children Not recommended for chrons disease, constipation, IBS in children at present.
Should not be used in seriously or chronically ill patients until safety is established
Questions unanswered
Accurate dose
Long term effect on gut micro flora of children
Regulation
Require pre-market review and approval by regulatory body (excl dietary supplements)
The safety, purity, potency & efficacy of the product must be demonstrated for approval.
The FDAs Center for Food Safety and Applied Nutrition regulates probiotics and prebiotics marketed as dietary supplements or food ingredients. Probiotics marketed for treatment and prevention of diseases are classified biological products & require FDA review & approval FDA has not yet approved any claim for probiotics that relate to reduction of risk of disease Structure-function claims are commonly used for probiotics & these do not require FDA approval
Regulation
No regulatory guidelines for probiotics in food in India ICMR has formed a task force which laid the following guidelines
Identification of genus, species & strains using standard methodology, as effect of probiotics is strain specific In vitro tests to screen the potential, eg, resistance to gastric & bile acids, antimicrobial activity against potential pathogen, ability to reduce pathogen adhesion, bile salt hydrolase activity In vivo safety studies in animal model (may not be necessary for strains with established documented use) In vivo efficacy studies in animal model Evaluation of safety in human use Evaluation of efficacy in human use (may not be needed for probiotics in food) Minimum effective dose should be clearly indicated
Regulation
If a probiotic food has a record of documented long & safe use outside India, the data could be reviewed & decided sufficient to allow marketing However labeling of health benefits will require efficacy studies conducted in Indian subjects Labeling requirements - Genus, species and strain designation - Viable number of organisms of each strain at the end of shelf life - Approved indications for use - Suggested serving - Suggested storage guidelines
References
Prebiotics & probiotics. World Gastroenterology Organization Practice Guideline. May 2008. ICMR-DBT Guidelines for Evaluation of Probiotics in Food.July 2011. Thomas DW, Greer FR. Clinical ReportProbiotics and Prebiotics in Pediatrics. Pediatrics.2010;126:1217-27