What reute do we take with Lactobacillus reuteri for antibiotic associated diarrhea? Iona Berger August 16, 2016

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1 What reute do we take with Lactobacillus reuteri for antibiotic associated diarrhea? Iona Berger August 16,

2 Objectives o Describe the evidence for probiotics (e.g. lactobacillus reuteri) for treatment and prevention of antibiotic associated diarrhea in a pediatric setting o Describe the adverse events associated with probiotics (e.g. lactobacillus reuteri) use o Apply the literature presented to our patient 2

3 Meet our Patient ID KW 2 mos 16 day old, 5.3kg, female admitted on July 26 CC Irritable and fever on admission (38.9 o C) HPI Hx of fever (39.2 o C), irritable and fussy x 2 nights Birth Hx Born at wks, SVD, Mom GBS +, mom didn t receive antibiotics Birth weight: 2.58 kg Allergies NKDA 3

4 Meet our Patient Immunization None KW was sick for 2 mos vaccinations PMHx MPTA Social history Previously healthy. Had a cough ~ 2-3 weeks ago, has resolved. Vitamin D 400 units PO daily Lives with mom, dad, and two older brothers at home Exclusively breastfed Family history Family ill 3 wks ago with congestion and cough Parents are both penicillin allergic 4

5 Review of Systems Vitals Tmax: 38.9 o C, HR: 176, RR: 40-60, O 2 sat: 96-98% on RA CNS Irritable, crying HEENT CVS RESP Unremarkable Unremarkable Unremarkable GI Feeding normally, mom reports more loose stools 5

6 Review of Systems GU/renal Liver Lytes/Fluids U/O: 0.9 ml/kg/hr, urine was cloudy. Renal U/S; no congenital abnormalities found U/A (07/26): +2 leuko, +1 nitrites, +4 blood, x 10 9 WBCs Unremarkable Na+: 138, K+: 8.0 (hemolyzed), HCO 3 : 15, Cl:103 Heme WBC: 18.9, Neuts: 10.4, Hgb: 101, Platelets: 496, CRP: 55 Endocrine MSK Derm Unremarkable Unremarkable Mottled skin colour, no rash 6

7 Microbiology Date Test Result July 26 CSF differential /stain +1 mononuclear cell, no organisms, lymph 16%, monocytes 84% July 26 Blood culture E. coli (after 18 hours) July 26 Urine culture E. coli >100 megacfu/l Sensitive Meropenem Amikacin Trimethoprim Resistance Ampicillin Cefazolin Ceftriaxone Cefotaxime Gentamicin Tobramycin 7

8 Medical Problem List Medical Problems Urosepsis Medications Meropenem 110mg IV Q8H (~60mg/kg/day) x 14 days (since start of meropenem, July 28) Acetaminophen 60mg PO Q6H PRN (11.1mg/kg/dose) Bone growth Vitamin D 400 units PO daily 8

9 Ruh-oh-uro-sepsis treatment caused complications Pt sent to BCCH for PICC insertion At BCCH BioGaia (Lactobacillus reuteri) started 2 0 to mom s concerns about antibiotic associated diarrhea Pt s mom requested that L. reuteri be started upon return to SMH 9

10 Medical Problem List Medical Problems Urosepsis Medications Meropenem 110mg Q8H (~60mg/kg/day) x 14 days (since start of meropenem, July 28) Acetaminophen 60mg PO Q6H PRN (11.1mg/kg/dose) Bone growth Antibiotic-associated diarrhea Vitamin D 400 units PO daily Lactobacillus reuteri (BioGaia) ordered 10

11 DTPs KW is experiencing increasingly watery stools (? antibiotic-associated diarrhea) and would benefit from reassessment of drug therapy KW is experiencing urosepsis and requires reassessment of drug therapy KW is at risk of vaccine preventable diseases and requires her 2 month vaccinations 11

12 DTPs KW is experiencing increasingly watery stools (? antibiotic-associated diarrhea) and would benefit from reassessment of drug therapy KW is experiencing urosepsis and requires reassessment of drug therapy KW is at risk of vaccine preventable diseases and requires her 2 month vaccinations 12

13 Antibiotic associated diarrhea 3 loose stools/day for 2 days Symptoms: Mild: watery, less formed stools w/ frequency Fulminant: watery diarrhea, fever, leukocytosis Complications include toxic megacolon, perforation, and shock. Antibiotics incidence of AAD: amoxicillin, amox-clav, cephalosporins and clindamycin 13

14 Antibiotic associated diarrhea Antibiotic therapy causes imbalance in colonic microbiota Microbiota alteration changes carbohydrate metabolism with short-chain fatty acid absorption and results in osmotic diarrhea Antibiotic tx can cause overgrowth of potentially pathogenic organisms, e.g. C. difficile 14

15 Goals of Therapy 1. Prevent morbidity (=dehydration, perianal rash, fulminant diarrhea) secondary to diarrhea 2. Alleviate signs and symptoms (increased frequency of runny stools) 3. Minimize adverse drug reactions 4. Educate family on antibiotic associated diarrhea 15

16 Alternatives Rehydration if dehydrated Discontinuation of provoking agent or changing antibiotic to one with risk of inducing diarrhea (e.g. quinolones, SMX/TMP, aminoglycosides) Probiotics: e.g. Lactobacillus reuteri 16

17 Proposed mechanism of probiotics Probiotics offer protection from potential pathogens by: o Providing colonization resistance o Enhancing mucosal barrier function by secreting mucins o Increasing tight junctions o Producing bacteriocins o Producing a balanced T-helper cell response 17

18 Guidelines CPS Statement (2015) Suggest benefits in using probiotics for: Prevention of antibiotic-associated-diarrhea Treatment of acute infectious viral diarrhea AAP Statement (2010) Suggest benefit of probiotics for prevention of AAD Do not recommend treatment of AAD with probiotics 18

19 Clinical Question Patient Pediatric (age <18) with antibiotic associated diarrhea (AAD) Intervention Probiotics (e.g. Lactobacillus reuteri) for treatment of AAD Comparison Placebo Outcome Efficacy: Diarrhea (# of watery stools, consistency of stools) Safety: Adverse events, precautions or contraindications

20 Search Strategy Databases Search Terms Limitations Results Medline/PubMed, Web of Science, Google Scholar 1. [Probiotics] 2. [Lactobacillus reuteri] 3. [Antibiotic-associated diarrhea] 4. [Treatment] 5. [Infant] or [child] or [adolescent] or [pediatrics] 6. [Prevention] [1] + [3] + [4] + [5] Not [6] [2] + [3] + [4] + [5] Not [6] Excluded trials about: prevention, C. difficile, gastroenteritis, amebiasis-associated diarrhea. Limited to: pediatrics, English language, available through UBC library 2 case reports

21 Case Report #1 P I Land MH, et al Lactobacillus Sepsis Associated With Probiotic Therapy 6 wk old with CVC, developed copious nonbloody diarrhea (3 days after treatment of antibiotics) Lactobacillus rhamnosus GG administered through gastrostomy tube. O Pt s diarrhea improved On day 20 of L. rhamnosus, pt developed fever, marked leukocytosis and appeared quite ill. CVC was found to be cultured with Lactobacillus species. Follow up CVC removed and oral Lactobacillus treatment discontinued Pt exhibited clinical improvement, and continued on 6 wks of antibiotic therapy to cure infection. 21

22 Case Report #2 P I Land MH, et al Lactobacillus Sepsis Associated With Probiotic Therapy 6 year old with CVC and several concurrent bacterial infections over 2 mos treated with antibiotics, experienced intermittent diarrhea (sometimes explosive, negative for Rotavirus and C. difficile). Lactobacillus rhamnosus GG (Culturelle) O On day 44 of L. rhamnosus tx pt developed fever (40.3 o C) and irritable Blood cultures revealed Lactobacillus growth on peripheral BCx and on implanted port. Follow up IV ampicillin to treat Lactobacillus infection and L. rhamnosus was discontinued 22

23 Conclusion Use caution with Lactobacillus rhamnosus GG in pediatric patients with CVC lines for the treatment of antibiotic associated diarrhea. 23

24 Limitations Evidence Quality Case reports are not high level evidence. Generalizability Both case reports had CVC lines Both were already hospitalized for many weeks prior to the AAD, representing a more clinically unwell patient population. Were on a different probiotic (L. rhamnosus) Both cases had complex past medical history (=cerebral palsy, congenital heart defects) 24

25 So is that it for L. reuteri? 25

26 Preventing AAD by ADDing Probiotics? How about the efficacy of L. reuteri for prevention of antibiotic associated diarrhea? 26

27 Georgieva et al Use Of The Probiotic Lactobacillus Reuteri DSM In The Prevention Of Antibiotic- Associated Infections In Hospitalized Bulgarian Children: A Randomized, Controlled Trial. P Children aged 3-12 years, n=100 admitted for acute infections Randomized, double-blind, placebo-controlled trial. Probiotic or placebo taken 2 hours after lunch daily, during entire duration of antibiotic therapy + additional 7 days. I Probiotic with 10 8 CFU Lactobacillus reuteri DSM (1 chewable tablet once daily) C Placebo O 1) Incidence of diarrhea during and up to 21 days post-antibiotic treatment 2) Incidence of mild diarrhea during and up to 21 days postantibiotics, severity of diarrhea, frequency of stool samples positive for C. difficile toxin, frequency of other GI symptoms 27

28 Results Outcome Placebo (n=48) L. reuteri (n=49) RR (95% CI) Primary outcome: Incidence of diarrhea during and up to 21 days post-antibiotic treatment 1 (2.04%) 1 (2.1%) 0.98 ( ) Secondary outcomes Mild diarrhea incidence (# episodes) 2 (4.08%) 3 (6.3%) 1.5 ( ) Mild diarrhea severity (# of stools) 8 17 Samples positive for C. difficile toxin 15 (31.3%) 13 (28.6%) 28

29 Limitations Allocation bias Low risk as pts randomized using a computer generated randomization program Placebo arm received identical chewable tablets to L. reuteri chew tabs Baseline characteristics NSS between two arms Performance and detection bias Low risk: double blinded study Attrition bias Minimal concern: <3% dropout rate Reporting bias Minimal frequency of diarrhea between both groups (inconsistent with literature which estimates 11-30% frequency of AAD) Lack of analysis of fecal L reuteri DSM levels Generalizability Aged: 3-12 years old 29

30 Conclusions No conclusion on efficacy of L. reuteri DSM on AAD in hospitalized Bulgarian children due to low incidence of AAD in study. No difference between groups regarding different gastrointestinal side effects. 30

31 Safety evidence for probiotics Safety concerns in the literature found for: S. boulardii à S. cervasiae fungemia Especially in immunocompromised or critically ill patients L. rhamnosus and L. casei à bacteremia and endocarditis Especially in immunocompromised or pts with CVC Endocarditis was noted in pts with recent dental manipulations or dental disease 31

32 Conclusion of the evidence (L. reuteri) Efficacy No evidence of L. reuteri (or other probiotics) in treatment of antibiotic associated diarrhea No conclusive evidence of L. reuteri in prevention of antibiotic associated diarrhea Safety Caution should be exercised when using L. rhamnosus (and other probiotics) in pediatric patients with CVC lines or immunocompromised patients 32

33 Relating it to KW Recommendations: Recommend to medical team to discontinue L. reuteri to KW Educate family about risks and unknown benefit of using probiotics in treatment of antibiotic-associated diarrhea 33

34 Monitoring Plan Expected change Frequency of monitoring Fever (>38.3 o C) Afebrile Daily No signs of dehydration (= sunken eyes and fontanelle, decreased feeding, decreased U/O, dry mucous membranes) Absence Daily Diarrhea (= # of stools/day, consistency of stools) Absence Daily 34

35 Follow up Pt s mom and medical team accepted pharmacy s recommendations to discontinue L. reuteri (BioGaia). Pt s stools did not increase in frequency or liquidity, and mom did not have new concerns about diarrhea. Pt successfully finished her antibiotic therapy! Pt received 2 month vaccinations at discharge 35

36 References 1. Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ [Internet]. 2002;324(7350): Available from: 2. Land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus Sepsis Associated With Probiotic Therapy. Pediatrics. 1976;115(1): Georgieva M, Pancheva R, Rasheva N, Usheva N, Ivanova L, Koleva K. Use Of The Probiotic Lactobacillus Reuteri DSM17938 In The Prevention Of Antibiotic-Associated Infections in Hospitalized Bulgarian Children: A Randomized, Controlled Trial. J IMAB - Annu Proceeding (Scientific Pap [Internet]. 2015;21(4): Available from: 4. Marchand V. Using probiotics in the paediatric population. Paediatric Child Health [Internet]. 2AD;17(10): Available from: 5. Thomas DW, Greer FR, American Academy of Pediatrics Committee on N, American Academy of Pediatrics Section on Gastroenterology H, Nutrition. Probiotics and prebiotics in pediatrics. Pediatrics [Internet]. 2010;126(6): Available from: 6. Mackay AD, Taylor MB, Kibbler CC, Hamilton-Miller JMT. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect [Internet]. 1999;5(5): Available from: 7. Enache-Angoulvant A, Hennequin C. Invasive Saccharomyces infection: a comprehensive review. Clin Infect Dis [Internet]. 2005;41(11): Available from: 8. Husni RN, Gordon SM, Washington JA, Longworth DL. Lactobacillus bacteremia and endocarditis: review of 45 cases. Clin Infect Dis [Internet]. 1997;25(5): Available from: 36

37 Thank you!

38 Acknowledgement Sandy Mok and the whole CYS team J 38

39 Questions? 39

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