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Probiotics Terms: •Probiotic – Probiotics are live microorganisms (bacteria or yeasts) which, when administered in adequate amounts, confer a health benefit on the host •Prebiotic - nutritional supplement taken to increase the amounts of beneficial bacterial in the gut or vagina. Example “FOS” (fructose oligosaccharides) •Biotherapeutic agent - microorganism used for specific therapeutic activity in humans •Nutriceutical - food products with beneficial effects in preventing or treating diseases Predominant Flora: Stomach Stomach (0-103 cfu/ml): Gram+ aerobes, Lactobacillus & Streptococcus Predominant Flora: Vagina Vagina: diverse aerobes & anaerobes including Lactobacillus jensenii, Lactobacillus acidophilus, Lactobacillus casei. Predominant Flora: Urinary Tract Kidneys: sterile Bladder: sterile Urethra: 101-102 E. coli Predominant Flora: Intestines Small intestine: Proximal ileum (103-104 cfu/ml) aerobic Gram+ Distal ileum (1011-1012 cfu/ml) Gram- anaerobes Colon (1011-1012 cfu/ml): Bacteroides, Eubacteria, Peptostreptococci, E. coli, Bifidobacterium, Fusobacteria Functions of Normal Flora Digestion Production of vitamins Mucosal maturation Stimulate Immune System Attachment Intestinal transit Colonization resistance Use of Probiotics in Larger Controlled Trials in Humans •Prevention of Diarrhea •antibiotic associated diarrhea •infantile diarrhea •traveler’s diarrhea •Treatment of Diarrhea • Clostridium difficile disease •acute diarrhea - pediatric and adult Saccharomyces boulardii and Antibiotic Associated Diarrhea in Hospitalized Patients N=180; site: University of Washington, Harborview Hospital Start Stop Stop Antibiotic Antibiotic Study Yeast continued for 14d Start Yeast (within 48h) Surawicz et al., Gastroenterol. 1989;96:981 Saccharomyces boulardii and Beta lactam Antibiotic Associated Diarrhea in Hospitalized Patients N=193; site: University of Washington, University of Kentucky Start Stop Stop Antibiotic Antibiotic Study yeast or placebo continued for 3d Start yeast or placebo McFarland et al. Am J Gastroenterol 1995;90:439448 Lactobacillus GG & Prevention of Infantile Nosocomial Diarrhea [Methods] DBPC in Poland 81 hospitalized children (1-36 months old) No diarrhea on admission Randomized during stay: – LGG (12 x 109 CFU/d) – Placebo Szajewska H. J Pediatr 2001;138:361-5. Lactobacillus GG & Prevention of Infantile Nosocomial Diarrhea [Results] 33.3 35 30 *p<0.05 % 25 20 16.7 15 10 5 6.7* 2.2* 0 Placebo (n=36) Szajewska H. J Pediatr 2001;138:361-5. L. GG (n=45) ND Rotaviral D’Souza et al., BMJ 2002;324:1361 Lactobacilli and Pediatric Diarrhea Treatment (L. rhamnosus and L. reuteri in hospital setting) 50 45 40 35 30 25 20 15 10 5 0 treated control dur (h) d5 dia (%) d5 rota(%) hosp days N=69 Rosenfeldt et al., Pediatr Infec Dis 2002;21:411 Huang, et al., Digestive Diseases and Sciences, Vol.47, No. 11 (Nov 2002) McFarlan d et al., JAMA; 271, 19131918, (1994). S. boulardii & High Dose Vancomycin for C. difficile Disease 60 % CDD recurrences 50% 50 *p=0.05 40 30 16.7% * 20 10 0 Placebo (n=14) Surawicz CM. Clin Infect Dis 2000;31:1012-7. S. boulardii (n=18) Rates of Clostridium difficile per 100 000 Patients in the United Kingdom General Practice Research Database Dial, S. et al. JAMA 2005;294:2989-2995. Copyright restrictions may apply. Comparison of Community-Acquired Matched Cases and Controls--Medication Variables Dial, S. et al. JAMA 2005;294:2989-2995. Copyright restrictions may apply. Clostridium difficile Disease • C. difficle makes 2 toxins. Recent strains are more toxinogenic •severity ranges from simple antibiotic associated diarrhea to mild colitis to pseudomembranous colitis to toxic megacolon to death •Relapses following treatment are common •Risk factors are antimicrobial exposure; recently gastric acid suppressive therapy has also been found to be a significant risk •All antibiotics have some (undefined) risk but those impacting the anaerobic intestinal microflora may have a higher risk (beta lactams, clindamycin, tetracyclines, etc) •Treatment is metronidazole 250mg QID as a first try. If treatment failure or relapse, use vancomycin PO 125mg QID. If failure, 500mg QID. •Use Saccharomyces boulardii probiotic to prevent relapses. Dose is 500mg BID for 4-6weeks. Other Uses for Probiotics –Limited Data •Crohn’s Disease •Ulcerative Colitis •Pouchitis •Allergy/Exema •Irritable Bowel Syndrome Dental caries •High Cholesterol Urinary Tract Infections •Helicobacter pylori • Lactose Intolerance •Candida vaginal infections •Bacterial Vaginosis Potential Advantages and Disadvantages of Probiotics Advantages Disadvantages Multiple Mechanisms of Action Few Controlled Trials Resistance is Infrequent Use May Reduce Exposure to Antibiotics Delivery of Microbial Enzymes Well Tolerated Benefit to Risk Ration is Favorable Persistence Possible Translocation Possible Transfer of Resistance Plasmids? Infection Possible Quality Control Issues Regulatory Issues in USA Lactobacillus rhamnosus GG Dietary Supplement: Culturelle Saccharomyces boulardii Dietary Supplement: Florastor Evidence supporting commercially available (USA) probiotics* condition L. acidophilus L. reueri LGG Sb AAD Uneven Good Good Good Acute Adult Acute pediatric Traveler diarrhea C. dif ? ? Good Good ? ? Good Good ? ? Fair Fair ? ? Limited Good BV Good** Good*** ? ? L. acidophilus=Lactinex; L. reueri=Probiotica; LGG=Culturelle; Sb=Florastor; ** strains tested not yet available in USA Probiotics Summary •Living microorganisms with multiple mechanisms of action •Good safety profile •Some applications to prevent and treat infectious diseases •An alternative to antibiotics in some situations •May have other applications, e.g. allergy, cancer, colitis, IBS •Product selection is very important