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Ferdinand Haschke Medical University of Vienna, Austria

Probiotics – Do They Work ? P revent ion / T reat ment of GI disease in pediatrics?. Ferdinand Haschke Medical University of Vienna, Austria Nestle Nutrition Institute, Vevey,Switzerland. DISCLAIMER.

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Ferdinand Haschke Medical University of Vienna, Austria

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  1. Probiotics – Do TheyWork?Prevention/Treatment ofGI disease in pediatrics? Ferdinand Haschke Medical University of Vienna, Austria Nestle Nutrition Institute, Vevey,Switzerland

  2. DISCLAIMER I wouldlike to thank Prof. HaniaSzajewska, Dept. Pediatrics, UniversityWarsaw, Poland, whoprovided me withchartsfromherpresentationat the Nestle Nutrition Institute Course in Singapore 2013.

  3. 10:1

  4. 10:1 Thereare10 timesmoremicroorganisms in and on usthan we havecellsthatmakeupour body (mainly in the gut) gutmicrobiota

  5. Gut microbiota • 1000 • Up to 1000 differentspecies of bacteria • 170 • Each individual harbors some 170 bacterial species out of a total of about 1000 that are predominant in the gut • 150 • The gut microbiota encode 150 times as many genes as our own genome Qin et al. Nature 2010;464:59-65.

  6. Differences in gut microbiota between healthy controls and disease states IBD Diabetes NEC Johnson & Versalovic. Pediatrics 2012;129:950-60.

  7. Differences in gut microbiota between healthy controls and obese subjects Obese subjects have lessvariability in their microbiotathanhealthy non-obese subjects.

  8. Gut microbiotamight be anessentialfactor in certainpathologicaldisorders Manipulation of the humanmicrobiome Effortsto optimize the intestinalmicrobial milieu haveincreased the interestin probiotics(and/orprebiotics)

  9. What are probiotics? Definition Examples Lactobacilli Bifidobacteria S boulardii • Live microorganismswhichwhenadministered in adequateamountsconfer a health benefit on the host Joint FAO/WHO ExpertConsultation 2001

  10. ProbioticsGenera, species, and strains Why the stain- not justprobiotics? All probiotics are not created equal Supplement companies makeunproven claims !!!!!! WHO Global Guideline. Probiotics and prebiotics. 2011.

  11. Whatare the implications of the strain-specifity? Documentation No extrapolation Dosage WHO Global Guideline. Probiotics and prebiotics. 2011.

  12. Mechanisms of action • Non-immunologic • Immunologic O'Toole PW, Cooney JC. InterdiscipPerspect Infect Dis. 2008;2008:175285 WHO Global Guideline. Probiotics and prebiotics. 2011.

  13. Effectiveness of interventions.Published RCTs & systematicreviews/meta-analyses on probiotics RCTs Meta-analyses 101 810 Cochrane Collaboration (search date: Jan 2013)

  14. For infants and children:Supplementation of infant formula with probioticsProvideclinicallyprovensupplements

  15. Prevention of Gastrointestinal Infections Administration of probiotic-supplemented formula beyond early infancy B lactis Bb12 3 RCTs RR 0.5 (0.36-0.8) NNT 7 There is evidence from the trials that supplementation of infant formula with B lactis Bb 12 is associated with a reduction in the risk of nonspecific GI infections. J PediatrGastroenterolNutr 2011;52:238-50.

  16. ESPGHAN Committee on Nutrition J PediatrGastroenterolNutr 2011;52:238-50.

  17. Supplementation of infant formulawith probiotics – term infantsESPGHAN Committee on Nutrition J PediatrGastroenterolNutr 2011;52:238-50.

  18. Treatment - Acute Gastroenteritis Whatis the evidencethatprobioticswork?

  19. AcutegastroenteritisDuration of diarrhoea Reducedduration of diarrhoea

  20. A common criticism Mixingapples & oranges

  21. AcutegastroenteritisDuration of diarrhoea LactobacillusGG 11 RCTs, n=2483 Saccharomycesboulardii 8 RCTs, n=1052 Reducedduration of diarrhoea Update: Szajewska et al. AlimentPharmacolTherap 2007;25:257-64 Szajewska et al. AlimentPharmacolTher 2009;30:960-1

  22. S boulardiiDiarrhealasting ≤4 daysCochranereview 2010 6 RCTs (n=606) RR 0.37 (0.21 to 0.65) NNT 3 (2 to 3)

  23. Treatment of acutegastroenteritisCurrentrecommendations

  24. Proportion of patients with waterydiarrhoea Otherprobiotics alsomay be usedprovidedtheirefficacyisdocumentedin high qualityRCTs (or in meta-analyses). ESPGHAN 2008 L reuteri 4 × 108 CFU Duration of diarrhoea L reuteri 2.1 ± 1.7 d Placebo 3.3 ± 2.1 d Meandifference -1.2 d (-2 to -0.3)

  25. Antibiotic-associated diarrhoea

  26. Prevention of AAD Total 63 RCTs N= 11 811 RR 0.58 (0.5 to 0.68) Children 16 RCTs RR 0.55 (0.38 to 0.8) Hempel at al. JAMA 2012;307:1959-1969

  27. 45% reduction in the risk of AADNumber needed to treat 11i.e. you have to treat 11 patients to prevent 1 from AAD

  28. Numberneeded to treat Slide from Dan Merenstein

  29. Numberneeded to treat Slide from Dan Merenstein

  30. Numberneeded to treat Slide from Dan Merenstein

  31. Numberneeded to treat Slide from Dan Merenstein

  32. Numberneeded to treat Slide from Dan Merenstein

  33. AAP recommendation Allprobioticsare not createdequal • Prevention of AAD • Thereissomeevidence to support the use of probiotics to preventantibiotic-associateddiarrhoea Thomas et al. Pediatrics 2010;126:1217-31.

  34. Prevention of Clostridium difficile-associateddiarrhea Johnston et al. Ann Intern Med. 2012

  35. Probiotics (as a group)reducedrisk of C. difficile-diarrhea 20 RCTs N= 3821 RR 0.34 (0.24-0.49) Johnston et al. Ann Intern Med. 2012 RCT, badanie z randomizacją

  36. Allprobioticsare not createdequal November 2012 Effectsize (example) S. boulardii (n=1232) 1.4% vs. 3.7% RR 0.39 (0.19-0.82) risk 61% Johnston et al. Ann Intern Med. 2012

  37. TREATMENT OF CLOSTRIDIUM DIFFICILE DIARRHEA Hot topic: Fecalmicrobiota transplantation (enema, colonoscopy, nasogastric tube) • TraditionalChinesemedicine (4th cent.) • Transplant «healthy» microbiota • Seems to besafe and works • Randomizedclinical trial: van Noodet al. Duodenal infusion of • donorfeces for recurrentClostridium difficile. N Engl J Med 2013 • Questions: dosage, timing, standardized «healthy» microbiota?

  38. IBD – probioticsupplementsfecalmicrobiota transplantation • No effect in Crohn`sdiease • VLS#3 probioticcombination + concomindanttherapy. Remission rate in ped. UC significantlyhigher (93 vs 36%) • Microbiota transplantation: mild-to-moderate UC: N=10 (pediatric); Enema daily for 5 days; Family or close relation. Clinical remission at 1 week (3); clinical response at 1 mo (6); Kunde et al, JPGN, 2013

  39. Nosocomialdiarrhoea

  40. Prevention of nosocomialdiarrhoea Whatisknown on thistopic?

  41. Whatisnew on thistopic?LGG in the prevention of nosocomialdiarrhoeaMeta-analysis 3 RCT, n=1043 RR 0.5 (0.4 – 0.7) NNT 13 (95% CI 9 – 28) Szajewskaet al. AlimentPharmacolTherap 2011

  42. L reuteri DSM 17938 in the prevention of nosocomial diarrhoea In hospitalizedchildren, the administration of L reuteri DSM 17938 comparedwith placebo had no effect on the overallincidence of nosocomialdiarrhea, includingrotavirusinfection Wanke & Szajewska. J Pediatr 2012;161:40-43.e1

  43. To useor not to useprobiotics for preventingnosocomialdiarrhoea?

  44. Prevention of nosocomialdiarrhoea Summary 2013

  45. Infantile colic • Prevalence • 3 to 40% of infants • Rationale for the use of probiotics • An aberrant gut microbiota in colicky infants • Lower counts of intestinal lactobacilli • Increased concentration of coliformis Savino & Tarasco. Curr Opin Pediatr 2010;22:791-7.

  46. Could something as simple as a probiotic supplementstop a colicky baby from crying so much?Newsweek, January 2011

  47. AAP 2010 Theremay be benefit for treatinginfantilecolic with probiotics, but furtherstudiesarenecessary. InfantilecolicL reuteri DSM 17938 L. reuteri DSM 17 938 at a dose of 108CFU/d in breastfedinfantsimprovedsymptomsof infantilecolicand was welltolerated and safe Day 7 Day 14 Day 21 Day 0 Day 21 0 Day 7 Day 14 Day 21 Savino et al. Pediatrics 2010;126:e526-33.

  48. TreatmentsuccessReduction on the dailyaveragecryingtime ≥50% Szajewska, Gyrczuk, Horvath. J Pediatr 2013;162:257-262

  49. Duration of crying Throughout the study period, the cryingtimewas significantlyreduced in the probioticgroupcompared with the placebo group Szajewska, Gyrczuk, Horvath. J Pediatr 2013;162:257-262

  50. Parentalpercetion of colicseverityFamily quality of life • Throughout the studyperiod, in the probioticgroupcompared with the placebo group: • reduction in the parentalperception of colicseverity • improvedparental/family quality of life throughoutthe study

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