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Probiotics Supplementation: What Pharmacists Need To Know
 

Probiotics Supplementation: What Pharmacists Need To Know

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  • Long before the existence of microorganisms was known or recognized, fermented products were used therapeutically, to treat colds, fevers, and ailments of the gastro intestinal tract such as constipation and diarrhea
  • Tooth decay and periodontal disease Vaginal infections Skin infections To treat diarrhea (this is the strongest area of evidence, especially for diarrhea from  rotavirus ) To prevent and treat  infections of the urinary tract  or female genital tract To reduce recurrence of  bladder cancer To prevent and treat pouchitis (a condition that can follow surgery to remove the colon) To prevent and manage  atopic dermatitis  ( eczema ) in children Cholesterol Colon cancer
  • U.S. Pharmacopeia’s (USP) new Dietary Supplement Verification Program (DSVP) is confusing and could mislead consumers into thinking the group’s seal means more than it really does, according to the Center for Science in the Public Interest (CSPI). The USP certification mark, which will begin appearing on at least one brand of dietary supplements later this year, means that USP vouches for the presence, quantity, and purity of a supplement’s ingredients—and not the supplement’s safety or possible benefits. Neither the mark, which says “Dietary Supplement Verified,” nor the accompanying explanation make that distinction clear, says CSPI. “ We applaud USP for trying to help consumers identify high-quality dietary supplements,” said CSPI senior nutritionist David Schardt. “But we are concerned that some consumers will assume that the USP mark means the product is safe and beneficial. USP risks losing its credibility if it is not clear about what is being certified and what is not.” For instance, says Schardt, if a bottle of ginseng pills bears the new USP seal, it means that USP certifies that the product contains the amount of ginseng listed on the label and that the ingredient is free from contamination. It does not mean that USP has tested and verified that ginseng provides additional energy or that it’s safe. A second major consumer group, the National Consumers League, expressed a similar concern about the clarity of USP's certification mark. “We hope that USP will go back to the drawing board and design something that will be clearer and convey to consumers that the product has not been tested for safety or efficacy,” said the League’s president, Linda Golodner.

Probiotics Supplementation: What Pharmacists Need To Know Probiotics Supplementation: What Pharmacists Need To Know Presentation Transcript

  • Probiotics Supplementation: What Pharmacists Need To Know Ali Alhammad, PhD Candidate Department of Pharmacotherapy and Outcome Science VCU School of Pharmacy January 31, 2012
  • Overview What are probiotics Probiotics Prebiotics Mymbiotics Efficacy How they work?? Possible health benefits Some products Regulations Safety How to choose the high quality products? Conclusions
  • Introduction How many of you are currently taking a probiotics or probiotics containing products?
  • What is Probiotics ??? “for life” in Greek Probiotics are live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host. FDA  Modify the endogenous microflora  Have a positive effect on the host
  • Prebiotics Nondigestible food ingredients  Fructo-oligosaccharides (chicory, inulin)  Lactulose Positively affect the endogenous micro flora Stimulate the growth of one or a limited number of bacterial species  FOS ⇒ Bifidobacteria  Lactulose ⇒ Lactobacilli
  • Synbiotics A probiotic organism in combination with its prebiotic food Providing both the organism and substrate at the time of ingestion may offer improved chance of survival in GI tract
  • Characteristics of EffectiveProbiotics Able to survive the passage through the digestive system Able to attach to the intestinal epithelia and colonize Able to Maintain good viability and stability of formulation Able to utilize the nutrients and substrates in a normal diet Non-pathogenic and non-toxic Capable of exerting a beneficial effect on the humans
  • Species Bacteria  Lactobacillus  Acidophilus, reuteri, casei, planatarum, rhamnosus “GG”  Bifidobacteria  Bifidum, breve, infantis, longum  Streptococcus Yeast  Saccharomyces bulardii
  • History Metchnikoff (1907)  Observed that lactic fermentation of milk stopped putrefaction  Suggested that consumption of fermented products would offer the same benefit to humans The term probiotic was first used in the 1960s“Death sits in the bowels; a bad digestion is the root of all evil” - Hippocrates, ca. 400 BC
  • Intestinal Flora 1014 viable CFU  More than 10-times total cells in the human body  More than total humans who have ever lived At least 50 genera > 500 species in any single adult  30 to 40 species account for 99% maintaining the balance of 85% beneficial and 15% harmful is key to personal wellness and health.
  • How they work ?? Competition with the pathogen for binding sites Bacteriocidal actions  Lowering intestinal pH  Production of organic acids  Immunomodulation  Metabolic mechanisms including:  Aiding digestion  Synthesizing vitamins  Increasing mineral absorption  Detoxifying carcinogens
  • Possible Health Benefits GI Disorders  Antibiotics Associated Diarrhea (AAD)  Irritable Bowel Syndrome (IBS)  Clostridium difficile Infection (CDI)  Ulcerative Colitis (UC)  Pouchitis  Lactose Intolerance  Infection with Helicobacter pylori (H. pylori) Boosts Immune System Other
  • Some Probiotics products Activia™ Yogurt  Florastor® Align®  Probiotic All-Flora® Culturelle®  Nutraelle® Lactinex®
  • Activia™ Yogurt Claim: “Regulates digestive system” Content: Bifidobacterium animalis Recommended dose: 1-3 servings (4 oz)/d Possibly effective:  Helicobacter pylori infection  IBS  Necrotizing enterocolitis  Pouchitis  Rotaviral diarrhea  Traveler’s diarrhea  Ulcerative colitis
  • Culturelle® Claim: several claims (GI, immune, diarrhea) Content: Lactobacillus rhamnosus GG, inulin Recommended dose: 1-2 capsules once or twice daily Possibly effective:  AAD  Chemotherapy-associated diarrhea  CDI  Nosocomial diarrhea  Traveler’s diarrhea  Prevention of allergies
  • Align® Claim: “Helps support digestive balance” Content: Bifidobacterium infantis Recommended dose: 1 capsule daily Possibly effective:  Helicobacter pylori infection  IBS  Necrotizing enterocolitis  Pouchitis  Rotaviral diarrhea  Traveler’s diarrhea  Ulcerative colitis
  • Regulation of DS 1994, Dietary Supplement, Health and Education Act (DSHEA) Not FDA regulated  FDA bas the “Burden of Proof”  Must prove that product is “unsafe”  No FDA enforcement unless can prove supplement is “unsafe”  (significant or unreasonable risk of injury)  Quality control is poor  80% of preparations tested had 1% or less of the bacterial concentration on the label
  • Safety Generally Recognized as Safe (GRAS) status  Lactic acid producing bacteria (included)  Bifidobacteria (not included)  Safe in literature  Very rare Endocarditis and Bacteremia Enterococci  Greater threat of Endocarditis and Bacteremia Several reports of fungemia associated with use of yeast-based probiotics (S. boulardii)
  • How To Choose…
  • How To Choose…
  • How To Choose… Consult your pharmacist and/or doctor
  • Supplement Facts Type of bacteria  Expiration/“Best by” Amount date Storage  Where it is made  Prebiotics
  • How To Choose … Look for standardized supplements (USP or ConsumerLab certification)  Contamination
  • Introduction How many of you are currently taking a probiotics or probiotics containing products?
  • Summary An old concept, with a new formulations Potential therapy for many GI related diseases and other Largely unproven, but growing body scientific evidence Patients need guidance as to which ones to use, when to use them, how to use them